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

Similar Jobs