| Job List |
| Job ID: |
TA-05220-1 - Clinical Data Analyst |
| Description: |
Job summary: The employee must conduct their work activities in compliance with all the company's internal requirements and with all applicable regulatory requirements. Iinternal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
The Principal CDA (Clinical Data Analyst) within Clinical Data Management will provide specialized knowledge and detailed attention to lead and carry out data management data review activities in support of one or more clinical research studies. The position is responsible for-
Working within clinical study teams as an extended team member.
Defining project timelines and executing the clinical data management operations against them, and any other priorities.
Using defined department metrics as a framework for timely and quality clinical data management deliverables.
Collaboration with peers within and outside the GDO organization to pro-actively manage data availability and integration.
Education and Experience
Degree or equivalent experience in Clinical Research, Computer Science, Project Management or related field: 8 years experience, BS/BA degree with 6 years experience, or MS degree with 4 years experience.
Minimum 3 years experience in a project lead role within a clinical data management organization, preferably within medium-large pharma or CRO.
Ability to travel 15%
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Salary: to 100k,
Job Type: Permanent,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
DS-05269-1 - Clinical Data Manager |
| Description: |
RESPONSIBILITIES:
Candidate will provide comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs
Serve as the Lead Data Manager on studies.
Customer negotiation on timeline, budgetary and other data issues
Develop presentations and present at investigator meetings
With minimal guidance, manage delivery of projects through full data management process life-cycle.
With minimal guidance, manage project timelines and quality issues, and identify and justify out-of-scope.
Provide input for negotiations with vendors.
Manage outside vendors
Complete external data reconciliation (i.e., ECG data)
Complete ongoing laboratory reconciliation
Provide comprehensive data management expertise (including all operations tasks and DMP generation oversight and approval).
Oversee the development of CRFs
Perform comprehensive quality control procedures
Communicate ideas for process improvement.
Provide input in developing and implementing new technology.
Understand and comply with core operating procedures and working instructions
Meet objectives as assigned.
Some knowledge of CDISC standards
Develop and maintain good communications and working relationships with Project Team
Interact with Project Team members to negotiate timelines and responsibilities as well as track overall timelines.
MINIMUM REQUIREMENTS:
Degree in clinical, biological, or mathematical sciences with a minimum of 7 years of experience in a clinical data management role.
Thorough knowledge of the data management
process
External Data Capture (EDC)
experience
Knowledge of Medical
Terminology, Pharmacology, Anatomy, and Physiology
Previous experience and proven competence in
managing delivery of project through full data management study
life-cycle (phase I and Phase II or Phase III).
Comprehensive understanding of clinical drug
development process
Excellent
organizational, communication, and data management skills (detail
oriented).
Ability to establish and
maintain effective working relationships with coworkers, managers,
and clients
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Salary: OPEN, Job Type: Contract,
Total Exp: 7 yrs,
Start Date: Asap,
Location: Fort Lee,
NJ |
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| Job ID: |
TA-05220-3 - Clinical Programmer |
| Description: |
Description:
Under
the direction of management leads the design, development,
validation, implementation, and provides ongoing support of
electronic systems (e.g., Oracle Clinical, Phase Forward),
reporting/business intelligence tools (e.g., Business Objects,
Spotfire) and programs (e.g., SQL, PL/SQL) used in Clinical Research
and Development studies.
Analyze Clinical
Study design requirements against third party system specifications
to support the implementation of electronic systems (e.g.,
electronic diaries) used in Clinical studies.
Assist in the validation of electronic
systems and programs as implemented internally or through external
vendors according to current regulatory requirements.
This position has matrixed responsibility to
Clinical Data Management, Clinical Programming, Statistical
Programming, Biostatistics, and the Clinical Research functions as
well as external vendors, to enable the analysis and implementation
of clinical information technology solutions.
Responsible for the role which includes
development, peer review and maintenance of database systems and
tools to support Drug Development activities.
Provide leadership and content expertise for
programming activities in support of Global Development to
effectively manage data capture, review and database lock
activities
Assist with the role which
includes Definition, Capture and Delivery of Clinical Study Data.
Peer review of deliverables.
Responsible
for the role which includes maintenance of Global Libraries and
ensuring their synchronization with department standards (e.g.
Standard data Elements).
Review and
approval of new programming objects prior to their use for Study
database set-up.
Responsible for the role
which includes development and finalization of the eCRF according to
the study specifications (e.g. Protocol, data Management Plan, Edit
Check Specifications).
Responsible for the
role which includes participation in the identification, evaluation,
recommendation, implementation and management of Clinical
Information technology solutions to support Clinical study database
activities including all forms of electronic data capture through
in-house or third party vendors.
Contribute to standardization of data capture, processing and
reporting through traditional and innovative electronic
solutions.
Support Corrective Action and
Preventive Action initiatives.
Qualifications:
Degree or equivalent experience in Computer Science, Life Science or
related field: BS/BA degree with 4 years experience, or MS degree
with 2 years experience.
Minimum 2 years
experience within a clinical programming organization, preferably
within medium-large pharma or CRO.
Minimum 2 years of experience working with Oracle Clinical and/or
Phase Forward systems
Ability to
effectively interact with and influence others without direct
reporting relationships
Technical
abilities and skills in analysis, design, specification and
programming of computer systems
Knowledge
and understanding of Regulatory Guidelines for the use of computer
systems in clinical studies
Analytical,
problem solving and technical skills
Knowledge of clinical Data Management and Clinical Programming
methodologies as well as current and emerging global industry
standards
Planning, organizational, and
project management skills
Negotiation
skills
Conflict management skills
Attention to detail with high quality outputs
Computer skills (word processing,
spreadsheets, graphics, PowerPoint)
Working knowledge of global standards related to clinical study data
management activities (CRF design, data standards, database design,
coding and coding dictionaries, etc.)
Ability to travel 5%
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Salary: Open, Job Type: Permanent, Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
TA-05089-1 - Clinical Project Manager |
| Description: |
Job Description :
The
primary responsibility is to manage both national and global
clinical projects and their associated clinical teams including
schedule and budget for clinical trial execution and ensuring
clinical trials are conducted in accordance with companys clinical
procedures, ICH GCP Guidelines, the Declaration of Helsinki and
national regulations.
Able to work
independently to manage all aspects of a clinical trial from the
site selection and vendor selection process to database lock and
review of the final clinical study report. Activities including
product inventory management, forms development, enrollment
management, timeline projections and the review of the final
Clinical study report.
Coordinate all
clinical trial activities while managing the interfaces with Legal,
Global Project Management, Data Management, Medical Writing,
Clinical Supply Chain, Clinical Compliance and Training, and
Biostatistics.
Effectively manage
external team/vendors activities including CRO, central lab, IRB and
other external contractors.
Interact
effectively with Sr. ! Management to provide updates and communicate
issues.
Review other study documents such
as protocols, Investigators brochures, DMPs, CRFs, SAPs, and FCSR.
As assigned, act as a regional TA
Operations counter lead to the Global TA Operations Manager for a
specific geography by providing operations support to all clinical
projects within the assigned Therapeutic Area (TA). Assist the
Global TA Operations Manager in resource allocation, setting project
timelines, and communicating significant issues to key stake
holders, in addition, ensure that information and training on the
conditions studied, the therapeutic approach, and the protocol
content is mirrored and aligned in all regions the TA is operating
in and that operational consistency is maintained to the largest
extent possible as coordinated by the Global TA Operations Manager.
Job Requirements :
BA/BS/Nursing or European equivalent education
and/or equivalent clinical research experience prefer minimum > 5
years of clinical experience in pharmaceutical, biotechnology or
medical device industry with 2 years project management experience.
Strong knowledge base of FDA regulations and ICH GCP Guidelines. For
Europe requirements, MS/MA or PhD with 1-2 years experience.
Has working knowledge and familiarity with US
Federal Food and Drug Administration, ICH/GCP, and European
Regulatory Authority requirements as applicable to a study.
Excellent verbal and written communication
skills required. Interpersonal and organizational skills a must.
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Salary: 110k, Job Type: Permanent, Total Exp: 3 Years,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
TA-01318-1 - Clinical Research Director - Bone |
| Description: |
Basic Qualifications - Medical Degree (MD)
- Two (2) or more years of clinical research
experience and/or basic science research
Preferred Qualifications:
Board eligible or certified in Endocrinology
(Bone Experience Preferred) or Rheumatology (Bone Experience
Preferred)
Clinical or basic science
research experience
Clinical teaching and
patient care
Experience functioning as a
medical expert in a complex matrix environment
Job Summary: Clinical
Scientist leaders are the medical experts identifying and executing
projects that substantially determine and contribute to late-stage
product development. Throughout the continuum of product
development, this role defines, analyzes and synthesizes commercial
input into clinical strategy including study design, data analysis,
and interpretation that is aligned with the overall direction of the
program. This role participates in the resolution of regulatory
issues, works with internal and external partners to enhance
international capabilities as well as managing and identifying
external collaborators, leaders and consultants for key
projects. |
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Salary: to 200K, Job Type: Permanent, Total Exp: 7+ Years,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
CM-06099-1 - Data Manager |
| Description: |
RESPONSIBILITIES:
Candidate will provide comprehensive data management expertise to
Data Management to provide efficient, quality data management
products that meet customer needs
Serve as
the Lead Data Manager on studies.
Customer
negotiation on timeline, budgetary and other data issues
Develop presentations and present at
investigator meetings
With minimal
guidance, manage delivery of projects through full data management
process life-cycle.
With minimal guidance,
manage project timelines and quality issues, and identify and
justify out-of-scope.
Provide input for
negotiations with vendors.
Manage outside
vendors
Complete external data
reconciliation (i.e., ECG data)
Complete
ongoing laboratory reconciliation
Provide
comprehensive data management expertise (including all operations
tasks and DMP generation oversight and approval).
Oversee the development of CRFs
Perform comprehensive quality control
procedures
Communicate ideas for process
improvement.
Provide input in developing
and implementing new technology.
Understand and comply with core operating procedures and working
instructions
Meet objectives as
assigned.
Some knowledge of CDISC
standards
Develop and maintain good
communications and working relationships with Project Team
Interact with Project Team members to
negotiate timelines and responsibilities as well as track overall
timelines.
MINIMUM
REQUIREMENTS:
Degree in clinical,
biological, or mathematical sciences with a minimum of 7 years of
experience in a clinical data management role.
Thorough knowledge of the data management
process
External Data Capture (EDC)
experience
Knowledge of Medical
Terminology, Pharmacology, Anatomy, and Physiology
Previous experience and proven competence in
managing delivery of project through full data management study
life-cycle (phase I and Phase II or Phase III).
Comprehensive understanding of clinical drug
development process
Excellent
organizational, communication, and data management skills (detail
oriented).
Ability to establish and
maintain effective working relationships with coworkers, managers,
and clients
Oncology trial experience preferred
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Salary: Open, Job Type: Contract,
Total Exp: 5 Yrs,
Start Date: Asap,
Location: Princeton,
NJ |
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| Job ID: |
TA-03189-7 - Director ,Regulatory Affairs |
| Description: |
Directly responsible for the organization and
preparation of IND/CTA submissions. Coordinates the activities
required to maintain the IND/CTA filings in Regulatory Compliance.
Participates in compliance activities including SOP
creation/revision and departmental training exercises.
ESSENTIAL DUTIES AND
RESPONSIBILITIES:
1.Direct the
preparation (content ) of submissions (INDs, IND amendments, CTAs,
CTA amendments, BLAs and BLA supplements and periodic reports) to
the Health Agencies. Responsible for coordination with Regulatory
CROs for CTA activites if appropriate.
2.Responsible for direct coordination /liaison
between Health Agency representatives and function groups within
ImClone.
3.Provide guidance to
multifunctional development teams concerning strategic decisions and
health authority interactions.
4.Responsible for liaison activities with
functional groups within ImClone to ensure timely and accurate
reporting of information.
5.Participates in
the creation, review and revision of the department policies, work
instructions and standard operating procedures.
ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:
1.BS/MS in life
science with minimum of 5 years experience in regulatory affairs
2.Must possess a thorough understanding of the
drug development/regulatory process with stong experience in
biologic oncology development.
3.Experience
in GCPs and regulatory compliance preferable.
4.Demonstrate a thorough knowledge of the
intent, meaning, interpretation and application of FDA and ICH
regulations. Knowledge of foreign regulations, guidelines and
practices for conducting clinical investigations is desired.
Travel Requirements :
Up to 10%
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Salary: to 150K, Job Type: Permanent, Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: Bridgewater, NJ |
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| Job ID: |
RC-05049-1 - Global Clinical Director - Women's
Heath |
| Description: |
Our client is a multi-billion worldwide
pharmaceutical company and a leader in the discovery, development
and commercialization of products in Womens Healthcare, Oncology,
Diagnostic Imaging and Neurology markets. The company is located in
Northern New Jersey.
Function:
The Global Clinical Leader will be responsible
for directing all strategic and operational clinical development
projects (phase II-III) or clinical life-cycle management activities
for marketed products in the area of Womens HealthCare, (ie.
hormone replacement therapy (HRT), oral contraception, etc.)
Key Responsibilities:
Leads the Global Clinical Development (GCD)
Team, a cross functional, multinational team of internal experts,
through clinical phase II-III trials, global product registration,
and ICMP trials supporting product life cycle optimization.
In consultation with relevant key disciplines,
prepares the Clinical Development Plan (CDP), including an
operational plan with high level resource planning, ie. timelines,
budget and manpower).
Responsible for the
ongoing risk-benefit assessment of a compound until approval in a
main country.
Analyzes incoming clinical
data, relevant medical and scientific information and initiates
actions or decisions as appropriate.
Provides medical expertise to Global Strategic
Marketing (for marketed products) and Strategic New Product
Marketing (for development projects) and dfines together with the
Marketing Manager for publication strategy.
Contributes to Opinion leader development and
publication strategy with implementation detail. Establishesand
maintains appropriate external scientific advisory boards and
assists in advocacy development.
Approves
publications and ensures consistency of publications with clinical
data and publication strategy.
Provides
medical assessment of in and out-licensing opportunities of
development projects.
Required
Qualifications: M.D. with 5 + years experience in Medical Science
and Drug Development. In-depth understanding of the drug development
and commercialization process involving womens healthcare
products,( ie. HRT, oral contracetion, etc.). Proven leadership,
motivational, communication and interpersonal skills.
Preferred Qualifications: M.D. with speciality
training in OB/GYN, Endocrinology or Internal Medicine. Credible and
internationally recognized medical expert who has completed
significant drug registration(s) on a global basis, including
US-FDA, and is familiar with all aspects of international medical
development involving womens healthcare products, (ie. HRT, oral
contraception, etc.).
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Salary: 230K base, Job Type: Permanent, Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: Northern NJ |
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| Job ID: |
RC-05229-1 - Global Clinical Manager Womens
HealthCare |
| Description: |
Function: Will be responsible for providing
support for Clinical Team Leads, helping to provide review of
studies (phase II-III) in large projects involving women healthcare
therapeutics, ie. Hormone Replacement , Oral Contraception, etc.
Responsibilities:
Defines the global clinical project concept
within the approved strategy incorporating the requirements of
regions and countries with a significant role in the clinical
project.
May lead a
clinical team and be a member of global teams.
Works with colleagues
to identify, assign and prepare resources for the clinical team.
Will set team objectives and clear responsibilities for team
members.
Will have
the responsibility of integrating regional development needs.
Plans the work steps
of the clinical project, and the required resources and timelines.
Working with the
Study Managers, proposes and/or approves clinical studies in the
regions.
Will
ensure medical/scientific basis and coherence throughout the entire
clinical project.
Identifies resources to perform medical
review/monitoring activities. You may perform the medical review.
You will support the medical review/monitor oversight.
Approves the baseline
study plan, final study core documents, including final study
protocol amendments and clinical study reports worldwide.
Assess acceptability of the safety profile and
prepare/update clinical risk assessment.
Requirements:
M.D. with experience in womens health care.
Minimum 5 years experience in drug development or equivalent. Strong
disease area/treatment knowledge in womens health therapeutics.
Understanding of the drug development process over different stages
is required. Experience in using clinical trial methodology and
technology. Experience in developing and delivering presentations.
Project management experience. Understanding of global regulations
and guidelines. Experience in regularly interacting with regulatory
agencies, effectively managing risk and compliance issues.
Experience in managing teams and participating in cross functional
teams.
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Salary: base to 200K, Job Type: Permanent, Total Exp: 5 Yrs,
Start Date: ASAP,
Location: Northern NJ |
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| Job ID: |
TA-03189-1 - Medical Affairs Manager |
| Description: |
Our client is a pharmaceuticals company that is
publicly traded. It is a specialty pharmaceutical company focused on
the development and commercialization of unique and uniquely
improved ophthalmic products for serious conditions of the eye.
In order for our
client to further build their pipeline as a specialty pharmaceutical
company, they expect to acquire complementary products in
ophthalmology, either already marketed or in late-stage development.
Their management team has extensive experience in the development
and commercialization of ophthalmic pharmaceuticals. Their
Ophthalmology expertise can be found in the Marketing, Sales,
Manufacturing, Clinical, Regulatory and General Management
functions.
If you
thrive on the challenge of launching products, and the rewards of
exceeding revenue targets while building a successful company, we
welcome your response!
The successful
candidate will report directly to the Director, Medical Affairs. As
a key member of the Medical Affairs team, the Medical Affairs
Manager serves as an extension of Medical Affairs in their region.
They contribute to the overarching strategy and tactics that are
important to assuring the proper direction and success of the
departments efforts.
Specific job responsibilities include but are
not limited to: identifying and communicating ideas from thought
leaders that are important for clinical and research initiatives,
development, support and delivery of regional medical education
programs, speaker development, identification of sites and
opportunities for company sponsored and investigator initiated
clinical trials, providing professional support to regional sales on
medical and clinical issues, and competitive intelligence. The
position requires a highly energetic professional who can deliver
consistent results in a constantly changing and relatively
unstructured daily environment.
Duties & Responsibilities:
Primary
Responsibilities
Medical affairs customer
relations management with key national and regional opinion leaders
and centers of influence.
Support,
development / delivery of regional medical education programs
Speaker development and maintenance
Phase 3b / 4 research trial site support and
investigator initiated research proposal cultivation and
facilitation.
Scientific support at key
regional and national congresses
Competitive intelligence gathering and assimilation
Responding to unsolicited off-label requests
that require personal communications
Hospital formulary, regional managed care and government account
support and presentations.
Other Responsibilities
Sales force support dictated by the magnitude
medical and scientific rigor required
Regional sales force medical and scientific product related
training
Territory management
Additional
Dimensions:
Customer relationship
management skills
Goal development /
Business planning / Execution / Documentation
Platform, small group moderator and one on
one presentation skills
Development and
delivery of reports and Business reviews utilizing MS word, Excel,
and PowerPoint.
Qualification Requirements:
Education &
Experience
Terminal Doctorate Degree
(Pharm.D., M.D., Ph.D)
Experience as
liaison in pharmaceutical industry preferred.
Post-graduate teaching and training
preferred
Knowledge
& Abilities
Firm background in
scientific methodology, general pharmacology and therapeutics
Understanding of basic clinical research and
statistics
Demonstrated excellent
commutations and presentation skills
Physical Demands and Work Environment
Ability to travel overnight
Ability to drive up to 3 hours
Ability to organize and work within a home
office environment
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Salary: 140k, Job Type: Permanent, Total Exp: 4 yrs,
Location: South Central
U.S. |
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| Job ID: |
TA-05220-2 - Medical Coding Specialist |
| Description: |
Job summary: The employee must conduct their
work activities in compliance with all internal requirements and
with all applicable regulatory requirements. Internal requirements
include compliance with ethics, environmental health and safety,
financial, human resources, and general business policies,
requirements and objectives.
Provides consistent and accurate coding using
standardized dictionary terminologies within company's Centralized
Coding Group (CCG). Provides quality review of coding performed by
the CCG, independent contractors or other third-party vendors (e.g.,
Contract Research Organizations) ensuring medical coding uniformity,
accuracy, and consistency. Manages assigned project timelines and
prioritization of tasks. Ensures compliance with regulations and
coding guidelines. Assists with updates and maintenance of medical
dictionaries and synonym lists. Provides input to coding processes,
standards, and guidelines ensuring consistent implementation of
procedures and standards. Supports the Centralized Coding Group with
coding related projects and resolution of dictionary or coding
related issues. Maintains a clinical understanding of medical
terminology, clinical research development, safety processes,
adverse event reporting, and standardized dictionaries. Represents
the end-user community on system teams supporting clinical data
coding activities. Ad hoc participant of the Dictionary Oversight
Committee (DOC).
Education and Experience
Degree or equivalent experience in a Health
or Health Science related field (e.g., RN, RPh): BS/BA degree with 6
years of relevant experience, or MS degree with 4 years
experience.
Minimum 3 years of experience
within a coding organization, preferably within medium-large pharma
or CRO.
Ability to travel 5%
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Salary: to 90k, Job Type: Permanent, Total Exp: 3-6 Yrs,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
TA-06269-1 - Medical Director |
| Description: |
Job Description
The
Medical Director is primarily responsible for clinical development
activities in the Global Pharmaceutical Injectables and Platform
Development businesses at the direction of the Therapeutic Area
Leader. The Medical Director is also responsible for directing
clinical development, new approvals, regulatory reports and
peer-reviewed manuscripts within the therapeutic area. Participates
on strategic teams including the identification of new indications
for existing licensed products and new products. This Medical
Director will provide Medical perspective and expertise in the
therapeutic applications of GPI products. The Medical Director is
accountable and takes ownership for clinical development plans,
clinical research studies and related development activities.
Incumbent will provide medical technical perspective to the Business
Development and Portfolio Management functions in the identification
of potential partnering and internal opportunities. Shares medical
expertise with his/her counterparts in other functional areas such
as Manufacturing, Quality, Assurance, Regulatory Affairs, R&D,
Legal and Marketing. This Medical Director will need to develop and
maintain strong scientific and medical relationships with
consultants as needed to support development programs.
1. Drive the
development of rational strategic plans for future clinical studies.
2. Act as Medical Monitor for clinical
research studies.
3. Capable of developing
communications plan, including publication plans for therapeutic
area.
4. Continuously develop and maintain
"state of the art" level of knowledge as to developments and trends
in medical sciences, especially in the designated therapeutic areas.
5. Serve as an expert consultant to quality
and medical vigilance functions in the investigation of adverse
events and other product related issues. Assist as requested in the
preparation of periodic/annual and other regulatory reports.
6. Strengthen relationships and develop new
relationships with consultants in business selected therapies
segments.
7. Understand core scientific
literature addressing clinical applications and safety of our
products and be prepared to utilize this information in response to
questions from internal and external queries.
8. Creates and encourages an environment that
stresses open, candid, and timely feedback relative to performance.
9. Continuously develop knowledge of
regulatory, pharmacovigilance, and quality assurance requirements in
alignment with Baxter Global Business Practice Standards.
10. Ensure compliance with all Business
Policies and Guidelines in accordance with the OIG (for US
staff).
11. Provide strategic leadership to
the clinical R & D and medical affairs activities related to the
evaluation and reporting of issues and adverse events related to
products safety and efficacy, as well as strategies and activities
associated with technical support for products in the global
market.
12. Provide medical and scientific
direction on clinical matters affecting preparation and submission
of timely and sound information to the worldwide regulatory
agencies.
13. Work with product development
and marketing functions to define the requirements and
specifications for new products
14.
Participate in the development and writing of Clinical Trial Concept
Sheets and Protocols. Provide input to investigators brochure and
interim/final Clinical Study Reports (CSRs). Approve final clinical
trial protocols, investigators brochures and CSRs. Develop clinical
sections of Regulatory submissions for CTAs and CTDs.
15. The position of Medical Director has a
worldwide scope and all clinical development activities must comply
with Good Clinical Practice (GCP) specifications as practiced in
different geographies.
Job Requirements
MD
degree, preferably with specialty training, (e.g. internal medicine,
oncology, infectious disease, BE/BC preferred for the US) or
equivalent training or experience.
Minimum of ten years of medical experience with five years of
clinical practice experience (Licensed physician). Experience in a
biotechnology or pharmaceutical company performing most or all of
the responsibilities in this position highly preferred.
Solid knowledge of GCP rules and regulations.
Excellent leadership capabilities;
teamwork oriented; interested in working in a multicultural and
cross-functional environment.
Strong
management skills; decisive; resourceful
Well developed interpersonal skills; strong in providing education
on complex scientific/clinical issues in a crisp and clear manner
both to a peer and larger audience.
Excellent verbal and written communication skills, public speaking
and teaching skills, Strong Microsoft Office skills required
Maturity, confidence and credibility to
advise and influence senior management
Strong business acumen and impeccable integrity
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Salary: 200+, Job Type: Permanent, Total Exp: 4-8 Yrs,
Start Date: ASAP,
Location: Chicago, IL |
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| Job ID: |
TA-06199-1 - Medical Director Pharmacovigilance |
| Description: |
SUMMARY
Medical case
review and data summarization of adverse events
DUTIES & RESPONSIBILITIES
Handle adverse events according to national
and international regulatory requirements and as per the
departmental and corporate SOPs
Ensure
adequacy of recording, summarizing, and handling of adverse events
for both investigational and marketed products including decisions
on seriousness and expectedness and causality
Ensure accuracy and timeliness of expedited
reports from postmarketing safety surveillance and from clinical
trials
Review literature articles (both
published and yet to be published) following established
procedures
Ensure accurate MedDRA coding
of adverse events from all sources
Author
Similar Event Analysis reports following established procedures
Review safety sections of clinical trial
protocols, investigator brochures, and informed consents for
selected drug development programs
Responsible for Pharmacovigilance signaling activities
Participation in Pharmacovigilance group
meetings
Attend the clinical team meetings
as a Pharmacovigilance representative for responsible products
Serve as a resource for the Medical
Information and Quality Assurance Teams
Assist and support the activities of the teams, Pharmacovigilance
and of Global Pharmacovigilance
Provide
expert advice on medical matters in general, and specifically on pre
and post-marketing safety-related issues
Participate and collaborate in the creation and review of
Pharmacovigilance Standard Operating Procedures and other documents
that support regulatory compliance
Communicate and collaborate effectively in safety matters with
Regulatory Affairs, Clinical Teams, Biostatistics, Data Management,
Marketing, and the Legal Department
Keep
management informed of special concerns and developing safety
problems with investigational or marketed products
Collaborate with consultants concerning drug
safety issues and pharmacoepidemiology studies
Provide strategic input to and in certain
instances lead safety analyses including, but not limited to
aggregates safety reports, labeling documents, clinical trial
protocols, investigator brochures, and Integrated Summaries of
Safety
Work with Clinical Teams and
Project Management and interface with CRO Safety
Perform such other duties as requested by
managementQUALIFICATIONSRequired
M.D.
degree or equivalent
MedDRA training (may
be provided after starting)
GCP training
(may be provided after starting)
Desired
Graduate
training/experience resulting in board eligibility/certification
Prior experience in pharmaceutical medical
research with specific experience in product
safety/pharmacovigilance/benefit-risk optimization
Postgraduate training in clinical
epidemiology and biostatistics
Specialization and experience in oncology
Experience:
Required
Practical
clinical experience/expertise
Desired
Individual
Case Safety Report handling, as well as periodic report, PSUR and
variation preparation
Expertise in
clinical research and safety activities in a pharmaceutical/biotech
company
Practical experience working with
MedDRA
Experience/expertise in
pharmacoepidemiology research
Management
experience
Skills/Knowledge
Required
Ability to
interact effectively with staff of multiple disciplines both within
and outside the company both nationally and internationally
Ability to manage/supervise activities in a
fast paced and changing environment to ensure objectives are met in
a timely manner and achieved within budget allocations
Ability to understand the safety database
Other:
Nature of the department and the information
that flows through the group requires that the individual be able to
work well and communicate effectively with people both inside and
outside of the department in order to meet deadlines. Person needs
to be able to adapt to the changing dynamics in workflow and react
accordingly. Due to the sensitive nature of the data received,
person must have integrity when handling the confidential data.
|
| |
Salary: Open, Job Type: Permanent, Location: Cambridge, MA |
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| Job ID: |
TA-04109-3 - Medical Science Liaison (MSL)
Midwest |
| Description: |
Description:
The
purpose of this regionally-based position is to develop excellent
working relationships with key therapeutic opinion leaders and
regional physicians of influence. These relationships shall be based
upon a two-way flow of information between the MSL and the target
physician regarding disease state management and with respect to
clinical and scientific developments of marketed ImClone products
and products in the near-term pipeline.
Major Responsibilities:
I. Support to External Customers
Provide regional management for the
investigator initiated clinical and pre-clinical trial program.
Serve as liaison between the company and
Oncology Cooperative research groups.
Identify key regional thought leaders and
priority customers, establish peer-based rapport, and function as
their primary scientific contact with the company.
Provide scientific/therapeutic information and
appropriate resources to clinical investigators
Act as liaison and consultant to provide custom
solutions which address specific needs/opportunities of priority
customers (e.g educational initiatives, investigator-initiated
studies, preceptorships, etc)
Provide access
to scientific presentation materials, including: approved
presentations, access to internal scientific personnel, and
publication assistance
II. Support to Regionally-Based Internal
Customers
Assist in the Identification of
priority customers (physicians, key ancillary health professionals,
pharmacy thought leaders, medical directors, policy makers)
Support the company's marketing and sales
leadership in strategic planning as well as business resource
allocation as they pertain to key investigators
Contribute scientific/clinical content
expertise to the development and execution of regional promotional
and educational activities
Actively
participate in presentations of scientific/clinical content to local
clinical audiences
Provide clinical science
support as needed in local formulary/institutional negotiations
Major
Responsibilities
III. Support to ImClone
home office internal Customers:
-Drive the
implementation of the the company's clinical trial program
-Work with the ImClone clinical trials group to
identify and screen potential investigators for company-sponsored
trials.
-Assist the clinical trials group as
needed in the support and communication with regional
investigators.
-Participate in the
collection and exchange of scientific/technical information
important to the company's business efforts
-Facilitate transfer of safety information as
needed from the practitioner to the company's drug safety
officers
Requirements:
The
successful candidate for this position will have the combination of
education and work experience which allows a strong command of both
the basic science and the clinical use of new therapies in oncology.
-Excellent written and verbal communication
skills are essential.
-Prior pharmaceutical
industry experience is preferred but not required.
-Persons with an advanced health care degree
with 2-5 years of work experience in the field of oncology are
encouraged to apply.
-Candidates must
demonstrate an ability to work both independently and
collaboratively with all functional areas of the company as well as
to be able to develop and leverage professional networks.
|
| |
Salary: to 160k, Job Type: Permanent, Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: OH, IN, MO, KS |
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|
| Job ID: |
TA-04109-1 - Medical Science Liaison (MSL) NE |
| Description: |
Description:
The
purpose of this regionally-based position is to develop excellent
working relationships with key therapeutic opinion leaders and
regional physicians of influence. These relationships shall be based
upon a two-way flow of information between the MSL and the target
physician regarding disease state management and with respect to
clinical and scientific developments of marketed ImClone products
and products in the near-term pipeline.
Major Responsibilities:
I. Support to External Customers
Provide regional management for the
investigator initiated clinical and pre-clinical trial program.
Serve as liaison between the company and
Oncology Cooperative research groups.
Identify key regional thought leaders and
priority customers, establish peer-based rapport, and function as
their primary scientific contact with the company.
Provide scientific/therapeutic information and
appropriate resources to clinical investigators
Act as liaison and consultant to provide custom
solutions which address specific needs/opportunities of priority
customers (e.g educational initiatives, investigator-initiated
studies, preceptorships, etc)
Provide access
to scientific presentation materials, including: approved
presentations, access to internal scientific personnel, and
publication assistance
II. Support to Regionally-Based Internal
Customers
Assist in the Identification of
priority customers (physicians, key ancillary health professionals,
pharmacy thought leaders, medical directors, policy makers)
Support the company's marketing and sales
leadership in strategic planning as well as business resource
allocation as they pertain to key investigators
Contribute scientific/clinical content
expertise to the development and execution of regional promotional
and educational activities
Actively
participate in presentations of scientific/clinical content to local
clinical audiences
Provide clinical science
support as needed in local formulary/institutional negotiations
Major
Responsibilities
III. Support to ImClone
home office internal Customers:
-Drive the
implementation of the the company's clinical trial program
-Work with the ImClone clinical trials group to
identify and screen potential investigators for company-sponsored
trials.
-Assist the clinical trials group as
needed in the support and communication with regional
investigators.
-Participate in the
collection and exchange of scientific/technical information
important to the company's business efforts
-Facilitate transfer of safety information as
needed from the practitioner to the company's drug safety
officers
Requirements:
The
successful candidate for this position will have the combination of
education and work experience which allows a strong command of both
the basic science and the clinical use of new therapies in oncology.
-Excellent written and verbal communication
skills are essential.
-Prior pharmaceutical
industry experience is preferred but not required.
-Persons with an advanced health care degree
with 2-5 years of work experience in the field of oncology are
encouraged to apply.
-Candidates must
demonstrate an ability to work both independently and
collaboratively with all functional areas of the company as well as
to be able to develop and leverage professional networks.
|
| |
Salary: to 160K, Job Type: Permanent, Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: Boston, VT, RI, CT, WV |
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|
| Job ID: |
TA-04109-2 - Medical Science Liaison (MSL) SE |
| Description: |
Description:
The
purpose of this regionally-based position is to develop excellent
working relationships with key therapeutic opinion leaders and
regional physicians of influence. These relationships shall be based
upon a two-way flow of information between the MSL and the target
physician regarding disease state management and with respect to
clinical and scientific developments of marketed ImClone products
and products in the near-term pipeline.
Major Responsibilities:
I. Support to External Customers
Provide regional management for the
investigator initiated clinical and pre-clinical trial program.
Serve as liaison between the company and
Oncology Cooperative research groups.
Identify key regional thought leaders and
priority customers, establish peer-based rapport, and function as
their primary scientific contact with the company.
Provide scientific/therapeutic information and
appropriate resources to clinical investigators
Act as liaison and consultant to provide custom
solutions which address specific needs/opportunities of priority
customers (e.g educational initiatives, investigator-initiated
studies, preceptorships, etc)
Provide access
to scientific presentation materials, including: approved
presentations, access to internal scientific personnel, and
publication assistance
II. Support to Regionally-Based Internal
Customers
Assist in the Identification of
priority customers (physicians, key ancillary health professionals,
pharmacy thought leaders, medical directors, policy makers)
Support the company's marketing and sales
leadership in strategic planning as well as business resource
allocation as they pertain to key investigators
Contribute scientific/clinical content
expertise to the development and execution of regional promotional
and educational activities
Actively
participate in presentations of scientific/clinical content to local
clinical audiences
Provide clinical science
support as needed in local formulary/institutional negotiations
Major
Responsibilities
III. Support to ImClone
home office internal Customers:
-Drive the
implementation of the the company's clinical trial program
-Work with the ImClone clinical trials group to
identify and screen potential investigators for company-sponsored
trials.
-Assist the clinical trials group as
needed in the support and communication with regional
investigators.
-Participate in the
collection and exchange of scientific/technical information
important to the company's business efforts
-Facilitate transfer of safety information as
needed from the practitioner to the company's drug safety
officers
Requirements:
The
successful candidate for this position will have the combination of
education and work experience which allows a strong command of both
the basic science and the clinical use of new therapies in oncology.
-Excellent written and verbal communication
skills are essential.
-Prior pharmaceutical
industry experience is preferred but not required.
-Persons with an advanced health care degree
with 2-5 years of work experience in the field of oncology are
encouraged to apply.
-Candidates must
demonstrate an ability to work both independently and
collaboratively with all functional areas of the company as well as
to be able to develop and leverage professional networks.
|
| |
Salary: to 160K, Job Type: Permanent, Total Exp: 3+ Yrs,
Start Date: ASAP,
Location: KY, TN, LA, MS, AR |
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|
| Job ID: |
RC-04019-1 - MEDICAL SCIENCE LIAISON (MSL), ONCOLOGY
|
| Description: |
POSITION OVERVIEW:
This position of Medical Science Liaison (MSL)
is field based located in a major metropolitan area, and will
support the companys Oncology franchise for both marketed and
development products. The company marketed products are for the
treatment of B-cell chronic lymphocytic leukemia, myelogenous
leukemia, and renal cell carcinoma. The company also has several
developmental pipeline products to treat other forms of cancer.
RESPONSIBILITIES:
The MSL will act as a
scientific expert between the company and the medical community
through the medical community through the dissemination,
clarification and education of scientific data and material.
Establishes long-term scientific/strategic relationships with key
physicians/scientists, related major medical associations, and
academic centers. Uses experience with key external medical and
pharmacy professionals through the process of one-on-one
interaction, small group discussions, and symposia lecture
presentations including exchanges associated with sponsored medical
education programs and protocols.
Facilitate
Key opinion leader (KOL) involvement in national, regional and local
educational forums including advisory boards and continuous medical
education (CME) venues.
Enable principal
investigators to develop their research interests by serving as
facilitator for investigator-initiated studies, and managing
submissions of letters of intent (LOI) to the internal review
committee.
Serve as the company liaison with
oncology cooperative groups, assisting strategic development of the
groups strategy.
Serve as an expert
consultant to internal cross-functional partners within the company
by providing product related scientific information and technical
support for training.
Responsible for
communicating relevant information from KOLs to key cross-functional
partners. Provide opportunities for top leaders to participate in
scientific forums, assisting in gathering resources for KOL projects
, such as research protocol funding, publications and presentation
of publication/abstracts/posters in national or Regional forums.
Leverage KOL networks,
CME contacts and current speaker development priorities to develop
program opportunities that highlight portfolio relevant disease
state information and management.
Responsible to ensure that Speakers are
thoroughly knowledgeable and trained utilizing the most current
information covering products
Serve as the
expert resource on products and associated disease states to Field
Sales and other internal cross-functional groups including :
Clinical Information Services, Scientific Communications, Phase IV
Research, Health Economics & Outcomes Research. Managed Markets,
Medical Research, Product Management, Sales Management, and Sales
Training.
Provide technical/scientific
information as well as guidance in the development of educational
programs needed to enhance corporate goals and initiatives.
Identify and develop potential speakers from
investigators working closely with each of them to ensure their
access to all relevant scientific information.
QUALIFICATIONS:
Requires a Bachelors degree in life sciences
with 6 years of pharmaceutical or related experience in clinical
oncology. An MD, PharmD or PhD with oncology clinical experience is
preferred with at least 4 years of pharmaceutical or related
experience in clinical oncology. Additionally, the candidate should
have 5 years experience as a health care provider or 5 years
experience with a biotechnology/ pharmaceutical company or contract
research organization and 2 years experience with Phase III/IV
trials, medical science liaison or clinical research associate with
experience in clinical oncology. Basic knowledge of oncology
products is preferred. Experience with Phase III clinical trials or
investigator-sponsored Phase IV trials is preferred. Must understand
the FDA/GCP requirements regarding clinical research trials. Ability
to travel approximately up to 60% of the time.
Abilities: Must be
able to understand, interpret and communicate complex scientific
information and data. Communicate comfortably with KOLs and groups
regarding technical information. Possess strong interpersonal,
strategic, leadership and communication skills. Skillfully influence
and persuade people. Possess in-depth scientific and technical
knowledge of company products versus competitors products plus the
disease states that are used in treatment. Obtain technical data
from the medical community, various company departments, and a
competitive marketplace, synthesize this information, and develop
logical and creative approaches to meet the customers needs while
achieving company scientific objectives.
Desired Clinical Experience: Post-doctoral
residency/fellowship training in one or more therapeutic areas such
as Oncology. Teaching experience such as lectures on related topics
presented at universities.
Continuing
medical education presentation experience. Research and related
publications experience
|
| |
Salary: 135K base, Job Type: Permanent, Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: IL, NY, MA, TX, GA |
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|
| Job ID: |
RC-04109-1 - MEDICAL SCIENCE LIAISON (MSL), ONCOLOGY
|
| Description: |
POSITION OVERVIEW:
This position of Medical Science Liaison (MSL)
is field based located in a major metropolitan area, and will
support the companys Oncology franchise for both marketed and
development products. The company marketed products are for the
treatment of B-cell chronic lymphocytic leukemia, myelogenous
leukemia, and renal cell carcinoma. The company also has several
developmental pipeline products to treat other forms of cancer.
RESPONSIBILITIES:
The MSL will act as a
scientific expert between the company and the medical community
through the medical community through the dissemination,
clarification and education of scientific data and material.
Establishes long-term scientific/strategic relationships with key
physicians/scientists, related major medical associations, and
academic centers. Uses experience with key external medical and
pharmacy professionals through the process of one-on-one
interaction, small group discussions, and symposia lecture
presentations including exchanges associated with sponsored medical
education programs and protocols.
Facilitate
Key opinion leader (KOL) involvement in national, regional and local
educational forums including advisory boards and continuous medical
education (CME) venues.
Enable principal
investigators to develop their research interests by serving as
facilitator for investigator-initiated studies, and managing
submissions of letters of intent (LOI) to the internal review
committee.
Serve as the company liaison with
oncology cooperative groups, assisting strategic development of the
groups strategy.
Serve as an expert
consultant to internal cross-functional partners within the company
by providing product related scientific information and technical
support for training.
Responsible for
communicating relevant information from KOLs to key cross-functional
partners. Provide opportunities for top leaders to participate in
scientific forums, assisting in gathering resources for KOL projects
, such as research protocol funding, publications and presentation
of publication/abstracts/posters in national or Regional forums.
Leverage KOL networks,
CME contacts and current speaker development priorities to develop
program opportunities that highlight portfolio relevant disease
state information and management.
Responsible to ensure that Speakers are
thoroughly knowledgeable and trained utilizing the most current
information covering products
Serve as the
expert resource on products and associated disease states to Field
Sales and other internal cross-functional groups including :
Clinical Information Services, Scientific Communications, Phase IV
Research, Health Economics & Outcomes Research. Managed Markets,
Medical Research, Product Management, Sales Management, and Sales
Training.
Provide technical/scientific
information as well as guidance in the development of educational
programs needed to enhance corporate goals and initiatives.
Identify and develop potential speakers from
investigators working closely with each of them to ensure their
access to all relevant scientific information.
QUALIFICATIONS:
Requires a Bachelors
degree in life sciences with 6 years of pharmaceutical or related
experience in clinical oncology. An MD, PharmD or PhD with oncology
clinical experience (THE CLIENT WILL NOW CONSIDER MS CANDIDATES!) is
preferred with at least 4 years of pharmaceutical or related
experience in clinical oncology. Additionally, the candidate should
have 5 years experience as a health care provider or 5 years
experience with a biotechnology/ pharmaceutical company or contract
research organization and 2 years experience with Phase III/IV
trials, medical science liaison or clinical research associate with
experience in clinical oncology. Basic knowledge of oncology
products is preferred. Experience with Phase III clinical trials or
investigator-sponsored Phase IV trials is preferred. Must understand
the FDA/GCP requirements regarding clinical research trials. Ability
to travel approximately up to 60% of the time.
Abilities: Must be
able to understand, interpret and communicate complex scientific
information and data. Communicate comfortably with KOLs and groups
regarding technical information. Possess strong interpersonal,
strategic, leadership and communication skills. Skillfully influence
and persuade people. Possess in-depth scientific and technical
knowledge of company products versus competitors products plus the
disease states that are used in treatment. Obtain technical data
from the medical community, various company departments, and a
competitive marketplace, synthesize this information, and develop
logical and creative approaches to meet the customers needs while
achieving company scientific objectives.
Desired Clinical Experience: Post-doctoral
residency/fellowship training in one or more therapeutic areas such
as Oncology. Teaching experience such as lectures on related topics
presented at universities.
Continuing
medical education presentation experience. Research and related
publications experience
|
| |
Salary: to 140k, Job Type: Permanent, Total Exp: 4-5 Yrs,
Start Date: ASAP,
Location: IL, MO, KS |
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| Job ID: |
CIR-06128-1 - Regional CRA - Los Angeles |
| Description: |
The Regional CRA manages the implementation of
study protocols at research sites. Responsibilities include but are
not limited to: serving as a CRA for clinical studies; performing
monitoring visits including site qualification, initiation,
monitoring and closeout visits; developing monitoring plan;
maintaining contact with study sites, report preparation and
communications documentation; conducting training; preparing for and
participating in Sponsor and FDA audits; managing clinical project
assistants and associates.
Required qualifications: BA/BS degree or
equivalent combination of education and experience in a medical or
scientific discipline; minimum 1 year regional monitoring
experience; significant technical, medical or industry experience in
a clinical research setting; strong understanding of Medical
Terminology, Physiology, and Pathophysiology; working knowledge of
Good Clinical Practices; strong organizational skills; the ability
to multi-task and work effectively in a fast-paced environment;
strong written and verbal communication and diplomacy skills;
professional demeanor and appearance; ability to travel.
Preferred
qualifications: BS in scientific discipline; 2+ years experience in
a CRO. They will consider an experienced CRC with oncology
experiencefor this position.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2-4 Yrs,
Location: Los
Angeles |
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| Job ID: |
CIR-06239-1 - Regional CRA - Memphis |
| Description: |
The Regional CRA manages the implementation of
study protocols at research sites. Responsibilities include but are
not limited to: serving as a CRA for clinical studies; performing
monitoring visits including site qualification, initiation,
monitoring and closeout visits; developing monitoring plan;
maintaining contact with study sites, report preparation and
communications documentation; conducting training; preparing for and
participating in Sponsor and FDA audits; managing clinical project
assistants and associates.
Required qualifications: BA/BS degree or
equivalent combination of education and experience in a medical or
scientific discipline; minimum 1 year regional monitoring
experience; significant technical, medical or industry experience in
a clinical research setting; strong understanding of Medical
Terminology, Physiology, and Pathophysiology; working knowledge of
Good Clinical Practices; strong organizational skills; the ability
to multi-task and work effectively in a fast-paced environment;
strong written and verbal communication and diplomacy skills;
professional demeanor and appearance; ability to travel.
Preferred
qualifications: BS in scientific discipline; 2+ years experience in
a CRO. They will consider an experienced CRC with oncology
experiencefor this position.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2-4 Yrs,
Location: Memphis,
TN |
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| Job ID: |
CIR-06239-2 - Regional CRA -Vancouver |
| Description: |
The Regional CRA manages the implementation of
study protocols at research sites. Responsibilities include but are
not limited to: serving as a CRA for clinical studies; performing
monitoring visits including site qualification, initiation,
monitoring and closeout visits; developing monitoring plan;
maintaining contact with study sites, report preparation and
communications documentation; conducting training; preparing for and
participating in Sponsor and FDA audits; managing clinical project
assistants and associates.
Required qualifications: BA/BS degree or
equivalent combination of education and experience in a medical or
scientific discipline; minimum 1 year regional monitoring
experience; significant technical, medical or industry experience in
a clinical research setting; strong understanding of Medical
Terminology, Physiology, and Pathophysiology; working knowledge of
Good Clinical Practices; strong organizational skills; the ability
to multi-task and work effectively in a fast-paced environment;
strong written and verbal communication and diplomacy skills;
professional demeanor and appearance; ability to travel.
Preferred
qualifications: BS in scientific discipline; 2+ years experience in
a CRO. They will consider an experienced CRC with oncology
experiencefor this position.
|
| |
Salary: OPEN, Job Type: Permanent, Total Exp: 2-4 Yrs,
Location: Vancouver,
BC |
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| Job ID: |
MS-01149-1 - Regulatory Manager - Device |
| Description: |
This is a unique opportunity to establish a
regulatory function within a well established and mature
manufacturer of Ophthalmic Diagnostic Equipment. Our client is
clearly a mover and a shaker in its industry, with a strong senior
management group that is focused on growth and to increase its
footprint in the ophthalmic industry.
Medical Device background a MUST with Ophthalmology preferred.
Interface with engineers and the
manufacturing arm of the company and the FDA submission
consultants.
Strong knowledge of
developing successful FDA submissions, 510K and PMA's.
Should have knowledge of 21 CFR Part 800
(device specific regulations).
The
position will evolve with time and capabilities of the individual to
grow the department.
Ability to interface
with all levels of management
Bio-Engineering background is desirable but not required.
International experience desirable but not
required
Open to about 25% of travel on an
as needed basis
Outstanding verbal and
written communication skills
Four year
degree is a must with an advanced degree a plus
Local candidates to NY/NJ/CT/PA and within a
reasonable commuting distance to the corporate office (some basic
relocation might be provided).
|
| |
Salary: to 125k, Job Type: Permanent, Total Exp: 4+,
Location: Paramus,
NJ |
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| Job ID: |
TA-04149-1 - Sr Manager Regulatory Affairs |
| Description: |
The incumbent is responsible for providing
regulatory input into contract negotiations, liaise with regulatory
contract research organizations (CRO) and monitor/track the CRO
compliance to contractual obligations. The qualified candidate will
provide specific project updates for CRO activities, work with
regulatory colleagues on the planning of submissions. Primary focus
of responsibility will be the interaction with the CROs for clinical
trial application (CTA) registrations, tracking budget changes and
negotiating contract requirements. In addition, the candidate will
be responsible for tracking new guidances and monitoring the
regulatory environment. When new information is found, the candidate
will summarize critical points and distribute to appropriate
personnel.
This
person must be highly organized, able to multitask, work well within
the team setting, and prior | |
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