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.