What are the responsibilities and job description for the Senior Medical Writer position at Actalent?
Position Summary:
Primary objective of the Senior Medical Writer is to provide technical and medical writing support to a variety of regulatory areas including CMC, non-clinical, clinical, and administrative submissions.
Key Responsibilities Include:
- Work with the clinical and regulatory teams to prepare protocols, protocol amendments, protocol synopses, schematics, study reports, investigator brochures, annual safety reports, and IND/IMPD clinical sections in CTD format under strict timelines.
- Ensure efficient formatting of documents, ensure a consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier.
- Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical, and regulatory documents for submissions.
- Lead the development of the annual medical writing timeline to ensure IB and other pertinent documents are updated as necessary.
- Assist in the writing of overview and other study related manuals (pharmacy manuals, lab manuals, etc.).
- Work with CRO’s to ensure study related documents are completed efficiently.
- Participate in the clinical sub-team.
- Other duties and responsibilities as required.
Experience:
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required.
- 10 years’ experience in a medical writing capacity within the pharmaceutical/biotechnical environment (or equivalent experience).
Skills, Knowledge & Abilities:
- Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
- Working knowledge of clinical research, study design, biostatistics, regulatory, and medical terminology preferred.
- Detailed knowledge of the requirements for preparation of key clinical, nonclinical, and regulatory documents for INDs, CTAs, and annual reports preferred.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Salary : $200,000
