At Facet, the Senior Medical Writer is focused on helping emerging companies advance their drug, biologic, device, and combination products through any or all stages of regulated development through the planning, preparation, and finalization of regulatory submission documents for submission to the US FDA.
To be successful, the Senior Medical Writer will be an integral part of a regulatory submissions team. The primary activity of the Senior Medical Writer is to plan, author, and finalize sound and persuasive scientific and regulatory arguments based on information from a variety of sources including, but not limited to:
- data available in the public domain;
- international and local (FDA) regulations and guidances;
- client protocols, study reports, other proprietary information;
- client goals, corporate objectives, and risk tolerance;
- the writer’s knowledge and experience with the regulatory, medical and commercial environment; and
- input from a multidisciplinary team including other Facet colleagues and Facet/client
The Senior Medical Writer will be accountable for direct interactions with the client and may be involved in FDA meetings as a scientific expert. Success requires strong interpersonal skills (e.g., good negotiation, conflict management), a willingness to bird-dog information, manage constructive criticism proficiently, and an ability to analyze complex issues and distill them into simple yet compelling messaging.
The Senior Medical Writer will:
- Serve as lead for multidisciplinary medical writing projects, as requested
- Prepare IND, NDA/BLA, DMF, 510k, and/or PMA regulatory submission documents using scientific data, literature sources and other relevant information provided by Facet clients
- Take ownership of a given assignment, proactively consulting other project team members (i.e. regulatory, clinical, nonclinical, CMC, biometrics) for information or guidance, as necessary.
- Perform standard QC functions (proofread copy for spelling/grammatical errors and fact checking of scientific content), as requested
- Maintain timelines and work within the assigned contract budget for writing assignments
- Be familiar with, and work in accordance with, US Federal Regulations, Good Clinical Practices and ICH guidelines, and Facet SOPs.
- Represent Facet on various cross-functional teams
- Maintain project budgets
- Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidances.
- Contribute to the development and maintenance of Facet and departmental working practices and procedures.
- Actively participate in service to the industry (e.g., industry memberships, conference presentations, publications).