| Job List |
| Job ID: |
TRS-02158-6 - Associate Director, Regulatory Affairs, Nonclinical |
| Description: |
Description:
The incumbent is responsible for but not limited to the following:
- Regulatory expertise within at least 1 related area including clinical trial management, manufacturing, non-clinical testing and marketed products together with broad understanding & experience in the clinical development process
- Support regulatory strategy & contribute to its outcome within the Nonclinical area
- Advise management & recommend departmental operating procedures/policies to accomplish work more efficiently & with better quality control
- Define regulatory vision & strategy for achieving that vision and engages and motivates team to buy into vision and execute strategy.
- Contribute to development results by providing regulatory leadership & assume a supervisory and/or "subject matter expert" role with regard to regulatory issues.
Qualifications:
• Associate Director: MD, JD, PharmD or Ph.D. in the life sciences highly desired. BS degree required in associated functional discipline (Life Sciences, Chemistry, Toxicology or Pharmacology)
• Associate Director: Minimum 10-12 years of regulatory experience plus 2-3 years of additional related experience (i.e., manufacturing, clinical marketed products, etc.) preferably including some broader industry experience.
• Must have experience in interacting with the appropriate regulatory bodies
• Most posess in-depth knowledge of appropriate Code of Federal Regulations & Regulatory Guidance Documents
• History of working in complex team environments with numerous/diverse stakeholders
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Salary: Open,
Job Type: Permanent,
Total Exp: 10-12 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-15 - Associate Director/Director, Sepsis and Anti-Infectives |
| Description: |
Description:
The incumbent is responsible for, but not limited to the following:
Primarily focusing on Infectious disease
Supporting the Sepsis/AI area function and strategy
Leading problem solving across the Sepsis/AI area with an enterprise-wide perspective: facilitating team(s) to identify issues and propose solutions
Contributing to development results by providing Sepsis/AI area leadership to assume a supervisory and/or "subject matter expert" role with regard to therapeutic area issues.
Bringing external market perspectives, sharing insight, and knowledge regarding therapeutic areas with groups within own department and across Eisai, as appropriate
Providing technical insight to ensure progress towards goals
Lead IPT or Study Teams, as appropriate
Qualifications:
MD, PhD or equivalent degree required
At least 3-5 years additional related experience for an MD or 7-10 years for a PhD (including academic research)
Experience in a field relating to Sepsis/AI
Medical expertise and development experience within an area relevant to Sepsis/AI especially as related to infectious diseases
Significant experience leading clinical trials
Working knowledge of other functional areas (e.g., Clinical Operations, Regulatory Affairs, Pre-clinical and Marketing)
Experience in translational research, working with pre-clinical scientists, leading study/project teams
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
RC-03058-1 - Associate Medical Director |
| Description: |
Company:
The company is a privately-held company that specializes in the development of topical drug/dermatology products for biotechnology and pharmaceutical clients. It provides a full range of product development services including formulation, clinical development, regulatory consulting, analytical support, cGMP clinical manufacturing and clinical labeling. Located in Northern California
Description:
The Associate Medical Director is responsible for medical affairs activities to support commercial brand strategies, and for providing medical support to clinical affairs for dermatology clinical programs in development
Specific responsibilities include:
• Provide clinical expertise and approval of clinical protocols, clinical study-related documents, clinical study reports
• Provide medical leadership of brand-related medical information and detail aids, clinical communications, publications, medical information
• Lead the development and execution of the post-approval clinical program in response to regulatory commitments and brand strategy supporting key medical marketing messages in partnership with commercial, regulatory, and clinical affairs
• Medical/scientific training of all relevant internal (e.g., marketing, sales, medical information) and external parties (e.g. speaker training) regarding the brand
• Works closely with the commercial team to help build awareness of products in the medical community
• Cultivate key opinion leader relationships and provide clinical leadership in interactions with key opinion leaders, advisory boards, patient advocacy groups
• Support the communication of scientific and medical information, specifically the presentation of key data to the medical community via advisory boards, national and international meetings, and other scientific venues.
• Provide support for the publication strategy and active involvement in the development of publications
• Provide clinical leadership in the evaluation and management of investigator initiated proposals and development of a process
Requisite Skills:
Specific skills needed include:
• MD or DO required with board certification/eligibility or equivalent in Dermatology
• Medical marketing experience is a plus
• Excellent written and verbal communication skills
• At least 2 years experience in a clinical/medical or industry setting
• Good understanding of strategic marketing acquired by experience or formal training
Capabilities:
Needed capabilities include:
• Strong computer literacy skills (including Word, Powerpoint)
• Attention to detail
• Effective planning (time and project management) skills
• Strong interpersonal, negotiation, communication, and problem solving skills
• Proven ability to work well in cross-functional teams
• Proven ability to form credible relationships with national opinion leaders, especially in the field of clinical dermatology |
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Salary: to 175K + Bonus,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Redwood City, CA |
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| Job ID: |
TRS-02158-16 - Associate Vice President - Global Therapeutic Area Head, On |
| Description: |
Description:
The chosen incumbent shall be responsible for but not limited to:
- Building an effective Oncology area to achieve business objectives.
- Providing input and support Oncology business strategy with an enterprise-wide perspective and contribute to its outcome.
- Responsible for organization and successful operating of advisory boards as necessary.
- Making Oncology area decisions with an organization-wide perspective.
- Act as a role model teamwork/collaboration in decision making process with respect to Oncology area decisions and process.
- Aligning business and Oncology area objectives across multiple project teams, departments, functions, and Eisai business units.
- Building a national/international reputation for excellence within the Oncology field.
- Oversight of the Oncology Therapeutic Area Globally.
- Working closely with marketing, business development and pre clinical research groups.
Qualifications:
- MD with training in Oncology.
- Minimum 10 years experience (including academic and industry).
- Minimum 2-3 years experience running a Therapeutic area or equivalent group with responsibility for multiple drug trials preferred.
- Proven ability to effectively interact with pre-clinical groups on complex scientific issues relating to the Oncology area required.
- Experience in entire clinical drug development process, including FDA/EMEA filing and product launches preferred.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-5 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-13 - Director, CNS |
| Description: |
Description:
The incumbent is responsible for but not limited to the following:
- Supporting the CNS are function and strategy.
- Leading problem solving across the CNS area with an enterprise-wide perspective: facilitating team(s) to identify issues and propose solutions.
- Contributing to development results by providing CNS area leadership and assuming supervisory and/or "subject matter expert" role with regards to therapeutic area issues.
- Bringing external marketplace perspectives, sharing insight and knowledge regarding therapeutic areas with groups within own department and across Eisai, as appropriate.
- Providing technical insight to ensure progress towards goals.
- Leading IPT or Study Team as appropriate.
Qualifications:
- MD, PhD or equivalent degree required, with MD preferred, with Neurology or Psychiatry specialty certification, and significant research background in Alzheimer Disease and or other dementias.
- At least 3-5 years additional related experience for an MD or 7-10 years for a PhD (including academic research).
- Significant experience in leading clinical trials.
- Working knowledge of other functional areas (e.g., Clinical Operations, Regulatory, Pre-Clinical, and Marketing).
- Experience in working with pre-clinical scientists and leading project/study teams.
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Salary: Open,
Job Type: Permanent,
Total Exp: 3-10 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
RC-03058-2 - DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS – HIV |
| Description: |
POSITION SPECIFICATIONS
DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS – HIV for a worldwide biopharmaceutical company engaged in the discovery, development and commercialization of anti-infective therapeutics; located in the SF, CA area.
OVERVIEW: Reporting to the VP of Medical Affairs, will have the responsibility to develop and implement medical strategies and clinical plans for the company’s HIV franchise. Contributes to the management of relationships with Key Opinion Leaders and directs clinical trial initiatives, assuring that clinical studies support the franchise strategy.
RESPONSIBILITIES:
Plans and delivers medical affairs strategies for the maximization of product potential and commercialization of HIV drug products.
Prepares and implements medical affairs research documentation, scientific summaries and regulatory documentation, including summaries and analysis of ongoing investigator-initiated studies and clinical study reports and protocol development for company sponsored clinical trials.
Contributes to the development and implementation of clinical plans and in particular Phase IV clinical strategy for HIV. Responsible for providing input into the therapeutic area and product strategy. Participates in product review and leads the medical affairs group on the HIV project team and manages a team of Phase IV HIV personnel. Ensures the timely development of documents which are medically and scientifically comprehensive for submission to key opinion leaders, advisory committees or other internal and external groups.
Writes protocols, including core background text, and scientific evaluation of study design, and assists in selecting efficacy/safety parameters and outcomes measures.
Assists in the preparation of abstracts, posters and communication for scientific meetings and conferences to maintain awareness of clinical research in HIV.
Works closely with the company’s Medical Scientist group and the Medical Education department in order to equip them with a total and enhanced view of the company’s HIV initatives and to promote stronger relationships with KOLs.
Develops appropriate alliances with internal clinical, regulatory, medical communications, and commercial groups in order to more effectively meet the needs and demands of the organization.
Collaborates with Commercial groups on projects such as Speakers meetings and training, Advisory Boards and scientific conferences and meetings in order to achieve the company’s scientific objectives.
Presents periodic therapeutic and business reviews for Medical Affairs staff and to senior management members. Represents medical affairs on cross functional teams involving clinical, regulatory, and marketing. Coordinates activities with the commercial groups to include the review of promotional materials.
REQUIREMENTS: Requires an MD preferably with ABIM board certification in Infectious Disease or Internal Medicine and related experience of 8-12 years with 3-5 years in a leadership and management role. Prior experience in medical affairs and experience in biopharma R&D is preferred. HIV clinical research experience is desired. Must understand the competitive landscape regarding the current diagnosis and treatment of HIV. Must be able to build consensus and drive projects to completion in a team environment. Must also demonstrate strong communication and interpersonal skills across the organization and have experience with committee based work projects. Should have a working knowledge of compliance-related topics relative to the biopharmaceutical industry through experience and/or formal training. Experience in fostering and maintaining relationships with Key Opinion Leaders in HIV; and the ability to maintain a high-visibility presence both inside and outside of the company.
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Salary: 200-250k,
Job Type: Permanent,
Total Exp: 8-12 Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
TRS-02158-17 - Director/Senior Director, Gastroenterology |
| Description: |
Description:
• Medical knowledge & expertise or industry experience within the GI Therapeutic Area
• Accountable for goals & objectives of a study
• Participate in advisory boards, as necessary
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Contribute to development results by providing GI Therapeutic Area leadership & assume a supervisory and/or "subject matter expert" role with regard to GI Therapeutic Area issues
• May make decisions for the GI Therapeutic Area on an EGC-wide perspective
Qualifications:
• MD or PHD with significant therapeutic area experience required. MD with specialty training within the therapeutic area(s) preferred
•? At least 5 – 7 years additional related experience for an MD or 10 – 15 years for a PHD (including academic research), preferably including some broader industry experience
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-5 - Director/Senior Director, Imaging |
| Description: |
Description:
The incumbent is responsible for, but not limited to the following:
A. Project –specific:
i. lead development (in conjunction with clinical teams , Imaging Group and external imaging KOLs ) an imaging biomarker strategy for PoC as well as compound profiling and registration trial endpoints.
ii. Interface with preclinical groups to develop possible tracers for target imaging /dose occupancy and to coordinate translational imaging in animal models to insure optimal bridging of imaging biomarker(s) into the clinic.
iii. Responsible for input into DDP/CDP regarding imaging strategies and for input to imaging components of projects through Imaging Advisory Boards/ involving expert imagers at project Ad Boards
B. Study-level:
i. Design imaging component for protocol concept sheet and full protocol (in conjunction with clinical team with review by Imaging Group).
ii. Identify technically qualified sites and imaging co-investigators for implementation of imaging components (critical for more advanced types of imaging)
iii. Identify imaging CRO/academic core lab for centralized analysis for multi-center studies, expert analysis for single center studies.
iv. Insure proper analysis and interpretation of imaging component data
C. General: ( Imaging Group Activities)
i. Develop template–type language for PCSs, protocols, CRF forms, informed consent forms for recurring types of PET /SPECT or MRI imaging
ii. Provide didactic information to teams on PET/SPECT and MRI imaging to facilitate understanding of imaging components.
Qualifications:
• MD and /or PhD with documented imaging expertise ( radiology, nuclear medicine /PET physician, imaging scientist, medical subspecialist with imaging experience ). Board eligibility and /or certification is desirable.
• Expertise in at least one imaging modality ( PET/SPECT , MRI, CT ). Experience in more than one therapeutic area is preferred( neurology, psychiatry, oncology , arthritis, cardiovascular). Experience in drug development ( minimum of 2 years) including early phase development and preclinical to clinical translation is highly desirable.
• Peer-reviewed publications and experience in scientific presentations
• Excellent verbal and written communication skills
• Good interpersonal skills and ability to work in a cross-functional team environment
• 15-20% travel (domestic and international)
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Salary: Open,
Job Type: Permanent,
Total Exp: 5+ Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-14 - Director/Senior Director, Oncology |
| Description: |
Description:
The incumbent is responsible for, but not limited to the following:
• Assuming (Global) leadership for one or more Oncology area programs
•? Defining Oncology/project vision and strategy for achieving that vision, and engaging and motivating teams to buy into that vision and execute strategy through clear and persuasive communication skills
•?? Providing technical insight to ensure progress towards goals
•?? Contributing innovative thinking and brings an external market perspective to task within and outside area of direct accountability
• Motivating exceptional performance
• Acting as an informal mentor and coach for team members
Qualifications:
•? MD with specialty training in Oncology
•? At least 5-7 years additional related experience including industry experience
• Medical and technical development expertise in tandem with strong working knowledge of other functional areas (e.g., clinical operations, regulatory, pre-clinical and marketing)
•? Sound knowledge of regulatory process on a global basis. Experience with regulatory filing highly desirable
•? Established reputation within the Oncology area
• Expertise in managing groups preferably across geographic regions
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
RC-03058-3 - DIRECTOR/SR DIRECTOR, MEDICAL AFFAIRS – HEPATITIS PROGRAM |
| Description: |
POSITION SPECIFICATIONS
DIRECTOR/SENIOR DIRECTOR, MEDICAL AFFAIRS – HEPATITIS PROGRAMS for a worldwide biopharmaceutical company engaged in the discovery, development and commercialization of anti-infective therapeutics; located in the SF, CA area.
OVERVIEW: Will have the responsibility to develop and implement medical strategies and clinical plans for the company’s hepatitis franchise (ie. HBV, HCV). Contributes to the management of relationships with Key Opinion Leaders and directs clinical trial initiatives, assuring that clinical studies support the franchise strategy.
RESPONSIBILITIES:
Will manage and direct medical affairs activities in support of investigational and marketed hepatitis products. Plans and delivers medical affairs strategies for the maximization of product potential and commercialization of drug products.
Prepares and implements medical affairs research documentation, scientific summaries and regulatory documentation, including summaries and analysis of ongoing investigator-initiated studies and clinical study reports and protocol development for company sponsored clinical trials.
Contributes to the development and implementation of clinical plans and in particular Phase IIIB/IV clinical strategy for hepatitis. Chairs the Phase IV subcommittee and is responsible for Phase IV proposal evaluation for the Hepatitis Project Team. Ensures the timely development of documents which are medically and scientifically comprehensive for submission to key opinion leaders, advisory committees or other internal and external groups.
Writes protocols, including core background text, and scientific evaluation of study design, and assists in selecting efficacy/safety parameters and outcomes measures.
Assists in the preparation of abstracts, posters and communication for scientific meetings and conferences to maintain awareness of clinical research in hepatitis.
Develops appropriate alliances with internal clinical, regulatory, medical communications, and commercial groups in order to more effectively meet the needs and demands of the organization.
Leads initiatives and collaborates with the Medical Science Liaison group in order to equip the MSL staff with a total and enhanced view of the company’s therapeutic initiatives; and to promote stronger relationships with key opinion leaders.
Collaborates with Commercial groups on projects such as Speakers meetings, Regional Consultant meetings and conference preparations. Also collaborates with medical communications in preparing conference presentation, manuscript review and publication planning.
Presents periodic therapeutic and business reviews for Medical Affairs staff and to senior management members. Represents medical affairs on cross functional teams involving clinical, regulatory, and marketing.
REQUIREMENTS: Requires MD preferably with board certification in Hepatology, Gastroenterology, Infectious Disease or Internal Medicine. Industry or Academic research experience or equivalent combination of experience with 5-10 years in clinical/medical affairs within the viral hepatitis area. Medical competency in the chronic hepatitis B area is preferred. Must have knowledge of the drug development process and the development of commercial strategies for hepatitis therapeutics. Prefer experience in developing and managing Phase III/b/IV protocols. Requires an understanding of business contracts and associated financial aspects coupled with strong clinical/scientific skills. Experience in fostering and maintaining relationships with Key Opinion Leaders in hepatitis. Must have strong leadership and management skills; well developed verbal and written communication skills and effective presentation skills; and the ability to maintain a high-visibility presence both inside and outside of the company.
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Salary: 200-250k,
Job Type: Permanent,
Total Exp: 8-12 Yrs,
Start Date: ASAP,
Location: San Francisco, CA |
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| Job ID: |
TB-07117-6 - Medical Director |
| Description: |
Job Description
You’re a strategic leader and problem solver with a strong ability to influence and drive a development team. You thrive in a rapidly changing, results driven environment, work well independently, and are a skilled problem solver. You not only have a deep regard for the science behind the drug, but you are keenly interested in the literature and changes within therapeutic areas. This position can lead to a Sr. Medical Director role in Clinical Operations.
Required Skills
Key Responsibilities
•Design medical monitoring and implement clinical trials through phases I-IV
•Co-manage a global development core team with clinical operations and other groups within clinical development
•Work on vital drug development programs
We’re looking for:
•US licensed MD with understanding of good clinical practices, and drug development through phases I-IV, including regulatory process
•PharmD or MD degree, and Board certified in Oncolgy in the US
•Two years’ drug development experience
•Excellent written, verbal, and presentation skills required
•Experience within a pharmaceutical or biotech company is preferred; some NDA or filing experience is a plus
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Salary: 200-250K,
Job Type: Permanent,
Total Exp: 2 Yrs,
Start Date: ASAP,
Location: Boston, NY, NJ, San Francisco, San Diego |
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| Job ID: |
CLM-01248-3 - Medical Writer |
| Description: |
JOB STATEMENT: Responsible for researching, writing, and editing clinical reports, summarizing data from clinical studies for submissions to the FDA and for publication and/or presentation. Assist in the development of formats and guidelines for clinical documentation. May also support CRA’s and MD’s in clinical protocol development. Keeps abreast of professional information and technology through conferences
JOB REQUIREMENTS / EDUCATION / EXPERIENCE:
Level 1:
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Requires a Bachelors/Masters degree in scientific discipline or equivalent with a minimum of 2 to 5 years experience with a Bachelors or 0-2 years with a Masters
• Demonstrated working knowledge of scientific principals.
• Normally receives no instructions on routine work, general instructions on new assignments
Level 2:
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
• Requires a Bachelors/Masters degree in a scientific discipline or equivalent with a minimum of 5-8 years experience with a Bachelors, or 2-5 years with a Masters and demonstrated working knowledge of scientific principals.
• May determine methods and procedures on new assignments and may provide guidance to other lower level personnel.
Level 3:
• Works on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables.
• Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results.
• Requires Bachelor’s/Master’s degree ina scientific discipline or equivalent with a minimum 8+ years experience with a Bachelors, or 5-8 years with a Masters and demonstrated working knowledge of scientific principals.
• Acts independently to determine methods and procedures on new assignments.
• May supervise the activities of other lower level personnel.
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Salary: OPEN,
Job Type: Permanent,
Total Exp: 2-8+ Yrs,
Start Date: ASAP,
Location: Atlanta, GA & Missassauga, ON |
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| Job ID: |
IN-09127-1 - Medical Writer |
| Description: |
Due to company growth, and a steadily increasing flow of regulatory documents into the clinical group, we are looking to fill a newly-created position within our Research & Development Department. This is a great opportunity for the right individual.
This is a full-time, direct hire, exempt position, and the job description is attached. The salary range is $60K to $65K, and we offer a bonus target potential of 10 percent of annual base salary.
The work hours are 8:30 AM to 5:00 PM, Monday through Friday.
In addition to salary and annual bonus, this company offers a comprehensive package of benefits including medical, dental, vision, paid life insurance and paid Long-term Disability.
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Salary: 60-65k,
Job Type: Permanent,
Total Exp: 3 Yrs,
Start Date: ASAP,
Location: Clinton, NJ |
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| Job ID: |
RG-11267-4 - Medical Writer |
| Description: |
Job Description:
Responsible for the writing and/or editing of a variety of scientific and medical documents and ensuring that they adhere to regulatory guidelines and departmental editorial standards. Documents include but are not limited to:
- protocols (clinical protocols (Phases I-III; IV), write clinical study outlines and protocols and draft documents in collaboration with
study team. Ensure protocol meets all regulatory and stylistic guidelines, contain an appropriate statistical analysis plan and will provide data needed for writing the CSR and scientific publications
- case reports forms,
- data tables, data listings, and data figures; ensure that statistics are presented accurately; prepare appropriate in-text tables to present data
- developing final study reports (Write clinical study reports (CSRs) for phase I; II; III; IV studies) Responsible for filing of completed CSR and appendices in repository;
- patient synopses
- investigators' brochures
- new drug applications (NDA)
- investigational new drug (IND) applications Maintain document standardization with the use of model documents/templates in order to ensure the quality of clinical project documentation
-Responsible for the QC of documents written by other authors. Responsible for proof reading own documents for consistency and compliance with internal and external guidance documents.
-Responsible for the importation of report appendix documents into a document management system. Confirms communications by obtaining required internal and external reviews; incorporating reviewer comments; proofing, editing, and revising copy; completing quality assurance checks, including case report forms (CRF) vs. protocols, statistical analysis plans (SAP) vs. protocol/annotated CFRs, data management plans (DMP) vs. protocol/annotated CFRs, case report tabulations (CRT)/listings vs. statistical analysis tables, clinical study report write-ups vs. statistical analyses and CRT/listings; obtaining final signoffs.
-Prepare clinical development plans and other clinical documentation as required Collaborate with counterparts to ensure timely preparation of publication plans and write abstracts, manuscripts and other materials as needed.
-Updates job knowledge by tracking changes in writing guidelines; participating in educational opportunities; reading professional publications; maintaining personal networks. Enhances organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments
Relocation Plan Available. |
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Salary: to 85k,
Job Type: Permanent,
Total Exp: 2+ Yrs,
Start Date: ASAP,
Location: Tarrytown, NY |
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| Job ID: |
PS-07076-4 - Medical/Sr Medical Writer |
| Description: |
Responsible for timely preparation of Clinical Investigator Brochures,
Clinical Development Plans (CDP), Clinical Study Reports, abstracts &
manuscripts, Integrated Summaries of Safety (ISS), Integrated Summaries of
Efficacy (ISE), Benefits/Risk Analyses, Annual Reports, etc.
Ensure high quality with regard to scientific content, organization,
clarity, accuracy, format, consistency and adherence to regulatory &
internal guidelines, styles & processes
Represent Medical Writing on clinical teams with responsibility for timely
& accurate completion of Medical Writing deliverables
Qualifications:
BS degree required, advanced degree preferred
5+ years pharmaceutical industry experience
Strong scientific, interpretive, organizational, communication, computer &
project management skills
Must be able to work efficiently in a team environment
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Salary: $80s,
Job Type: Permanent,
Total Exp: 5+ years,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
PS-07076-3 - Quality Manager, Medical Writing |
| Description: |
Responsible for the overall quality control of all clinical documents
Review documents from various sources for accuracy and completion
Ensure data, tables, charts, statistical analysis, etc. in documents are
valid
Ensure there is a cohesive, uniform style and language throughout the
documents
Qualifications:
Minimum BS/BA degree in English and/or Life Sciences
5+ years experience in the pharmaceutical industry
Working knowledge of FDA and ICH Guidelines, AMA Style Guide, Medical
Terminology, and relevant The company SOPs
Excellent organizational and communication skills |
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Salary: $95k-$110k ,
Job Type: Permanent,
Total Exp: 5+ years,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-3 - Senior Director/Director, Clinical Pharmacology |
| Description: |
Description:
The responsibility of the Director is to assist in the drug development process by:
- Leading IPT's in early and full drug research.
- Designing and conducting clinical pharmacology and clinical studies required to evaluate new drugs and to obtain approval of investigational drugs.
- Preparing and review of reports necessary to achieve regulatory approval.
- Reviewing protocols for other studies.
- Preparing/Presenting study results.
- Compiling appropriate regulatory documents.
Qualifications:
- M.D., Ph.D. or equivalent degree.
MD or PHD with significant therapeutic area experience required. MD with specialty training within the therapeutic area(s) preferred
At least 5 – 7 years additional related experience for an MD or 10 – 15 years for a PHD (including academic research), preferably including some broader industry experience
- Broader industry specific experience preferred.
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Salary: Open,
Job Type: Permanent,
Total Exp: 5-7 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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| Job ID: |
TRS-02158-18 - VP/Assoc VP/Sr. Director Global Therapeutic Area Head - CNS |
| Description: |
Description:
• Primary focus on Epilepsy and Movement Disorders
• Build an effective CNS area to achieve business objectives
• Provide input to & support CNS business strategy with an enterprise-wide perspective & contribute to its outcome
• Responsible for organization & successful operation of advisory boards, as necessary
• Make CNS area decisions with an organization-wide perspective
• Role model teamwork/collaboration in decision making process with respect to CNS area decisions & processes
• Align
business & CNS area objectives across multiple project teams, departments, functions & Eisai business units
• Build a national/intermational reputation for excellence within the CNS field
• Oversight of the CNS Therapeutic Areas in both the US & UK
Qualifications:
• MD with neurology specialty
• Minimum 10 years experience (including academic research)
• Minimum 2-3 years experience running a therapeutic area or equivalent group with responsibility for multiple drug trials
•
Experience in entire clinical drug development process, including FDA/EMA filing, product launches & a proven ability to effecitvely interact with pre-clinical groups on complex scientific issues relating to the CNS area required
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Salary: Open,
Job Type: Permanent,
Total Exp: 10 Yrs,
Start Date: ASAP,
Location: Ridgefield Park, NJ |
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