Job Description
Responsibilities:
- Clinical / medical writing experience – pref. in oncology
- Experience at bringing together submission content (Mod 2.5, 2.7 etc)
- Experience at working with internal clinical SMEs, pulling together their content into briefing documents / submission content
- Prior knowledge of Pfizer systems is desirable but not mandatory East coast based preferably
- Write, edit, and format various regulatory documents, publications, and presentation materials for NDA submission
- Coordinate document review cycles, incorporate comments, and collect signatures for finalization
- Develop and maintain timelines for document/publication review and finalization
- Assist in the development of in-house medical writing materials for NDA submission (such as SOPs and style guide)
- Provide quality control (QC) review of various regulatory documents
- Collaborate with others and effectively represent Medical Writing/ Clinical Regulatory on inter-departmental project teams
Qualifications:
- A minimum of a BS degree and 3+ years’ experience in a pharmaceutical, biotech or CRO environment
- Demonstrated solid knowledge and experience in Medical Writing and/or Clinical Regulatory (IND, NDA, briefing books, DSUR, Literature Writing etc.)
- Recent experience with an NDA submission desired
- Experience writing and managing clinical regulatory documents
- Knowledge of science and clinical research concepts
- The ability to understand and summarize clinical data
- Writing ability for different types of clinical and regulatory documents
- Knowledge of FDA and ICH guidelines
- Demonstrated solid project management skills
- Proven experience in working in a high volume environment handling multiple tasks
- Excellent time and priority management, able to work efficiently under pressure
- Works accurately and to detail
- Strong organizational skills
- Strong computer skills, including Word, PowerPoint, and Excel
- Excellent grammatical and communication skills, both written and oral
- Expertise with electronic publishing desired
- Proven ability to interact seamlessly and collaboratively with client in a consulting relationship
Additional Information
All your information will be kept confidential according to EEO guidelines.
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