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| Job ID: |
RC-09239-1 - ASSOCIATE DIRECTOR SCIENTIFIC COMMUNICATIONS |
| Description: |
ASSOCIATE DIRECTOR SCIENTIFIC COMMUNICATIONS for a worldwide pharmaceutical company and a leader in the discovery, development and commercialization of products in Hematology, Oncology., Women’s Health, Diagnostic Imaging and Neurology markets; located in the Northeast.
FUNCTION:
Reporting to the Head of Global Scientific Affairs, will be responsible for supporting projects for the Hemostasis therapeutic area. The major duties will involve publication planning, development and tracking, medical and scientific writing, scientific communications, support of scientific symposia and meetings; advisory/scientific KOL boards, and clinical training.
RESPONSIBLITIES:
Provides regular updates for KOL Extranet site, proposes innovative and interactive content and executes in cooperation with outside vendor.
Creates scientific manuscripts, abstracts, posters/oral presentations for publicationor presentation to the medical community. Copy development either by directly writing, reviewing or by supervising medical writing vendors.
Guides publication projects through internal and external review processes with adherence to good publication practices.
Provides updates to the KOL and speaker database in cooperation with regions/countries.
Maintains a study and publication tracking database that contains key information on non-clinical and clinical trials, medical marketing key messages, target abstract, poster and manuscript development project timelines. Regularly distributes reports of publication activities to key internal stakeholders.
Organizes and maintains an electronic publication library for manuscripts, abstracts and posters related to the Hemostasis therapeutic area and to future products.
Supports regions/countries with requests to support specific scientific communication objectives.
Provides editorial services for region/country scientific publicationand presentation activities upon request.
Updates scientific brochures, product monographs, training materials and scientific Brand Plan content in collaboration with cross-functional partners.
Supports the organization of the company satellite symposia at congresses, the company hemophilia awards program dinner and Advisory or Scientific KOL boards, including the new company hemophilia awards program alumni scientific meeting.
Organizes hemophilia clinical training program with one host clinic each in regions of Latin America and Asia Pacific.
Makes proposals for new KOL development projects and executes, if jointly accepted.
Helps review promotional material of the Global Brand Team and provides input for new material.
QUALIFICATIONS:
Advanced degree (PhD or PharmD or equivalent) in a scientific or medical discipline with a minimum of 3 years in a pharmaceutical company working on scientific communication projects. A background in the area of hemophilia or hematology is desired. Experience in scientific publication processes is required including medical writing, and an understanding of good publication practices. Must have an excellent ability to interpret complex scientific and clinical trial data and a demonstrated ability to present scientific information in a clear and succinct manner to internal and external audiences.
Experience in planning and organize scientific meetings. Must possess strong interpersonal skills to motivate individuals, including KOLs and company personnel around the world. Must be creative, innovative while maintaining a high level of productivity. Must be a team player with sensitivity to diverse cultures.
Must be able to work simultaneously on various projects and support different team members. Ability to coordinate and communicate with internal cross-functional partners and external KOLs to achieve common goals and to ensure deadlines are met.
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Salary: 125K,
Job Type: Permanent,
Start Date: ASAP,
Location: Princeton, NJ |
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TA-09049-1 - Associate Director, Clinical Affairs |
| Description: |
Worldwide healthcare company located in the Chicago area. The company is a leader in the discovery, development and commercialization of anesthesia and critical care products including inhalation anesthetics, cardiovascular beta-blocking agents; and intravenpus (IV) solutions; premixed drugs and drug reconstitution systems, prefilled vials and syringes for injectable drugs, infusion pumps and other related products to deliver fluids and drugs to patients.
Responsiblities
The Associate Director, Clinical Affairs will apply specialized theoretical and practical knowledge to a broad range of clinical and clinical development situations. This individual will devise new approaches/solutions to technical and clinical situations through adaptation and modifications of standard clinical principles and distributive pharmacy practice including IV room experience. The person in this position is recognized as proficient within the area of clinical specialty to offer guidance to the marketing, business development, and research and development teams of Baxter Pharmaceutical Technologies. This individual will also participate in the design, conduct and analysis of studies and other regulatory documents to support development of drugs and medical devices for regulatory submissions and to differentiate products in terms their ability to reduce healthcare-acquired infections and/or reduce medication errors.
Requirements
The Associate Director, Clinical Affairs is either a clinically skilled, licensed PharmD or Pharmacist or equivalent scientific degree. The candidate must have a minimum of 3 years Hospital/IV room experience. Recent or ongoing work in a clinical position and experience in clinical development of new products (drugs and/or medical devices) is desirable. The candidate must have a minimum of 8 years clinical research experience with 4 years experience at a healthcare, pharmaceutical or clinical contract research organization. Knowledge of companyr products, including device and competitive products is helpful. The individual must have excellent verbal and written communication skills, excellent presentation and teaching skills, be computer literate, and willing to participate in a team approach. In addition, the individual must demonstrate exceptional follow-through with assigned tasks, and be self-motivated.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 3 Years,
Start Date: ASAP,
Location: Chicago |
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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 company’s 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, Investigator’s 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-07239-1 - Director, Pharmacovigilance |
| Description: |
BJob Summary
This is an opportunity for a Director position in the PBRAM group within Company’s Global Safety. The PBRAM group provides
continuous assessment, management and timely communication of the benefit/risk profile for all Company’s products.
Role/Purpose:
-The Global Safety Officer (GSO) leads by establishing the direction and priorities of the GST and is accountable for all
product safety related GST decisions for assigned products
-Key interface between the GST, TAH, AGS Sr. Management, GRA, and other Company’s functional areas including Global
development
-The GSO supported by the GSSL is responsible for the timely communication of safety recommendations and/or actions
from the GST to internal and external stakeholders
-This role leads single projects which can be of moderate or high complexity/scope or multiple projects of lower complexity
closely collaborating with the Therapeutic Area Head
Key responsibilities include:
-Lead responses to regulatory enquiries regarding safety, including evaluating the question, assigning responsibility,
determining data needs, reviewing, approving and submitting the response
-Develops and supports action plans to evaluate safety concerns, internal review and escalation, risk management strategy,
execution, and communication
-Lead development of strategy and creation of product risk management plans including maintenance and updates
-Manages quarterly product safety reviews execution and closure of recommendations
-Accountable for safety content of Global Development Plans
-Contribute to and sign off on DMC and adjudication charters
-Represent AGS at meetings with Regulatory authorities
-Participate in planning, review and sign off of clinical trial safety documents for content (includes CSS, 120 Day safety
update, protocol safety sections, CSR#s, ICF#s, study safety monitoring plans, Investigator Brochures)
-Drive and support the development and maintenance of DCSI and CDS safety sections via leadership of the GST
-Provide input to potential in-licensing opportunities, safety interactions, and pharmacovigilance agreement with commercial
partners
-Participate in planning, provide strategy and content input, and sign off on aggregate safety reports (e.g. PSURs, ASRs)
-Accountable for identification, assessment, and communication of potential safety signals as leaders of GST
pharmacovilance activities
-Responsible for regulatory inspection readiness within functional group
-Manage GST in support of Therapeutic Area Head ensuring workload/resource planning
-Collaborate, review and sign off SOPs, Business Practices, and Training Manuals as necessary.
Basic Qualifications:
-Medical Degree (MD) or international equivalent
-Previous management experience
Preferred Qualifications:
-Accredited fellowship or clinical experience in relevant therapeutic area specialty
-Clinical experience, including training
-Previous drug safety, biotech/ pharmaceutical or regulatory agency experience
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 7+ Years,
Start Date: ASAP,
Location: Southern CA |
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| Job ID: |
MG-09259-1 - Manager, Regulatory Affairs |
| Description: |
Responsible for all activities of the Regulatory Affairs Department. Main objectives are to file and obtain ANDA approvals and to ensure compliance with FDA regulations. This will include submitting quality submissions of ANDAs, AADAs, Supplements and Amendments; reviewing and submitting Annual Reports, Annual Drug Reviews, Adverse Drug Experiences, interfacing with QA, NPD and manufacturing in data generation, providing for product development and reformulation, interpreting regulaltions and supervising staff. EEO-M/F/D/V
5+ to 7 years of experience
Management Experience Required - Yes
Minimum Education - Bachelor's Degree
Willingness to Travel - Occasionall |
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Chicago |
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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.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Location: Los Angeles |
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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.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-4 Yrs,
Location: Vancouver, BC |
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JH-11099-1 - Sr Project Manager- ISCHEMIA |
| Description: |
Position summary: A major medical university is recruiting a full-time Senior Project Manager for our busy cardiovascular clinical research program. We are seeking a bright, energetic, well organized and detail oriented individual who possess strong analytical abilities and capable of handling diverse responsibilities and managing a large staff. At least 5 years experience managing an international multi-site clinical trial and managing an NIH funded research program is a must.
The PROJECT MANAGER coordinates the operational and financial management of a multi-center international randomized clinical trial which will enroll 6,000 patients, in more than 300 sites in thirty countries.
Key Accountabilities - Assure Goals of ISCHEMIA grant are realized
1. Develop consent form and protocol and amendments
2. Oversee site initiation (IRB approvals, consent forms, contracts).
3. Assist the Chair in submitting all yearly NIH non-competitive renewals documentation.
4. Monitor overall protocol adherence.
5. Field questions from the sites on regulatory and IRB issues.
6. Coordinate with the Data Coordinating Center staff and Co-PI's staff as well as staff at the other coordinating centers and core labs.
7. Correspond with local coordinators regarding corrective measures including errors in data forms or excessive edits.
8. Serve as a central resource for site and other central unit coordinators.
9. Oversee and manage Clinical Coordinating Center office and staff, including all ISCHEMIA trial staff .
10. Oversee central site monitoring, including review of signed informed consent forms and source document vs CRF’s concordance.
11. Manage staffing issues including staff replacement/recruitment, training as needed, staff work schedule and payroll.
12. Oversee closeout activities at all sites including notification to Institutional Review Boards of study end.
13. Prepare materials for dissemination of trial results to study participants
Experience/Requirements
1 Should have a Nursing degree or Masters degree in Public Health, Public Administration or a medically related field.
Requires five years experience managing an international multi-site clinical trial and managing an NIH funded research program is a must.
2 Must have experience coordinating large, complex team efforts.
a. For example, experience identifying project risks, working towards specific goals, achieving consensus in a group, resolving conflicts, etc.
3 Requires excellent interpersonal, organizational, communications and strong writing skills.
4 Experience working with the FDA
5 Experienced in working with multiple subcontractor relationships, various core laboratories, clinical events, and web-based site education
6 Requires expertise with Microsoft Office (Word, Excel, Powerpoint, Access, Project). HTML expertise strongly preferred.
7 Some familiarity with health information technology, especially clinical information systems, preferred.
8 Experience in health policy, health quality and safety, and / or interoperability of health information technology issues, preferred.
9 Familiarity with regulatory compliance issues and day-to-day oversight of the trial’s operational activities.
10 Assist all ISCHEMIA investigators with manuscript development.
11 Work with writing groups to ensure compliance with schedule for development of analysis plan and drafts and final manuscripts.
12 Prepare manuscripts for publication including creating tables and figures.
13 Format manuscripts according to journal specifications.
14 Assist with publication of articles; editing and creating tables and writing appropriate sections.
15 Provide editorial review of manuscripts.
16 Track submitted manuscripts through the revisions and publication process.
17 Act as liaison between co-authors for manuscript editing and (re)submission.
18 Perform literature reviews for reference material.
19 Facilitate response to reviewer comments after journal review, and collation of co-author input.
20 Willingness to travel outside New York in fostering collaboration with other interoperability projects
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Salary: 115-130K,
Job Type: Permanent,
Total Exp: 5 Yrs,
Start Date: ASAP,
Location: New York, NY |
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