Senior/Principal Medical Writer

Actalent is seeking experienced medical writers to collaborate with a leading pharmaceutical company on a consultant basis for an initial 12-month contract. Successful candidates will possess: At least 3 years of relevant experience in writing study-related and submission-related clinical and regulatory documents. Proficiency in drafting protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and Briefing Documents. Experience in writing Common Technical Document (CTD) modules, such as m2.5 Clinical Overview and m2.7s CTD summaries, and responding to Health Authority queries. A track record of writing documents for at least 3 drug products in Oncology and Immuno-oncology. Leadership in delivering individual documents, setting clear expectations for timelines and quality. Expertise in leading scientific discussions within assigned documents, interpreting clinical data, and presenting it clearly and concisely. Strong engagement skills with document stakeholders, effectively managing diverse viewpoints and objectives. The ability to anticipate issues, propose effective solutions, and escalate when necessary. Experience in leading and facilitating productive meetings.

Location: UK, GB

Posted Date: 1/15/2025