Job Description
Job Summary:
We are seeking a detail-oriented and experienced Senior Medical Writer to join our clinical development team on a contract basis. The ideal candidate will apply advanced writing and document management skills to produce high-quality clinical and regulatory documentation supporting global drug development. This role involves close collaboration with cross-functional teams and adherence to regulatory standards.
Responsibilities:
- Draft and edit regulatory submission documents (e.g., CTDs, RtQs), clinical protocols, protocol amendments, informed consent forms, investigator brochures, and safety reports (PSURs, DSURs).
- Manage the full document lifecycle including planning, drafting, review coordination, comment adjudication, and finalization.
- Facilitate cross-functional meetings and maintain timelines to ensure timely document delivery.
- Apply regulatory and company writing standards, including AMA, CBE, and Chicago Style guidelines.
- Interpret and present clinical data in text and table formats using appropriate scientific language and referencing.
- Collaborate effectively with teams across Clinical, Biostatistics, Regulatory, Medical Affairs, and other functions.
Qualifications:
- Bachelor’s degree or higher, preferably in a life science or medical discipline.
- Minimum of 6 years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
- Proven expertise in drafting clinical and regulatory documents, including protocols, clinical study reports, INDs, and BLA/NDA components.
- Strong understanding of clinical research, regulatory requirements, and drug development lifecycle.
- Familiarity with medical dictionaries (e.g., MedDRA, WHO Drug), biostatistics, and clinical coding practices.
- Certification in medical writing or related training (e.g., AMWA, EMWA, DIA) is a plus.
Job Tags
Contract work,