Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and efficacy of our existing and pipeline products to produce safe, effective, innovative medicine.
The Associate Director works with scientists in our Company Research & Development (R&D) Division and external investigators to write or facilitate the writing of journal articles, conference abstracts, and posters/oral presentations that report our Company's clinical trial results and, at times, early-stage development and other scientific work, for timely peer-reviewed publication. In conjunction with other areas, including Clinical Research, Biostatistics and Research Decision Sciences (BARDS), Center for Observational and Real-world Evidence (CORE), Regulatory Affairs, Clinical Pharmacology, Translational Medicine, Drug Safety, and Basic Research, identify key issues for publications, define hypotheses and sources of data, and review data analysis plans for assigned franchise(s).
- Be intimately familiar with science/literature of assigned therapeutic area(s). Develop and maintain an awareness of key data and insights regarding the emerging product profile and disease area within assigned therapeutic area(s). Be knowledgeable and conversant with most complex issues/questions in these areas, and able to discuss these issues/questions with opinion leaders and others as a peer.
- Work with the Global Scientific and Medical Publications (GSMP) Publication Manager and members of the Publication Teams for assigned therapeutic area/franchise to execute the Publications Strategy Plan when a product candidate enters Phase III, or sooner. The plan will be incorporated in the Product Development Team’s (PDT’s) objectives and updated as appropriate.
- Interact with GSMP Publication Managers to ensure adherence of Publication Teams to the Publications Strategy Plan.
- Present and defend data at scientific forums and participate in our Company organized meetings, domestic and international, as appropriate.
- Advocate our Company publication guidelines and other good publication practices and oversee the Office of Scientific and Technical Information Clearance (OSTIC) manuscript release process.
- Ensure that franchise publication/presentation tracking information is accurately and actively maintained in Datavision and other relevant repositories.
- Attend training courses and appropriate scientific meetings to maintain competency in and awareness of relevant external research activities.
Education Minimum Requirements
- Medical Doctor (MD) or a Doctorate (PhD) or its equivalent in the biological sciences, biostatistics or epidemiology and a minimum of 5 years experience in scientific writing resulting in peer-reviewed publications or a Bachelor or Master of Science (BS/MS) and approximately 12 years of scientific writing experience resulting in peer-reviewed publications.
Required Experience and Skills
- Demonstrated leadership and competence in biomedical research and strong writing skills
- Understanding clinical pharmacology, clinical research methodology and biostatistics is mandatory
- Oncology publications experience required
Preferred Experience and Skills
- Industry (pharmaceutical industry and/or contract agency)
- Proficiency with Microsoft Office programs is expected, and familiarity with database programs and methods of data display is very helpful.
- Immuno-oncology experience preferred
* Remote opportunity available if not within commutable distance to PA or NJ site.