Principal Medical Writer - Contract - Wilmington DE
Proclinical is seeking an innovative Principal Medical Writer to lead a dedicated team.
Primary Responsibilities:
This role will be responsible for developing clinical documents for global regulatory submissions. The successful candidate will work closely with multidisciplinary project teams to create scientifically valid, complete, and consistent documents such as clinical study protocols, clinical study reports, Investigator's Brochures, and other regulatory documents. This position requires a broad understanding of clinical research processes and global regulatory standards. The Principal Medical Writer will also oversee medical writing activities for multiple compounds and serve as the lead writer on major submissions.
Skills & Requirements:
- Bachelor's degree in a life science discipline; Master's degree preferred.
- Proficient understanding of domestic and international regulatory requirements.
- Strong organizational, time management, and project management skills.
- Proficiency in MS Word and experience with template systems (e.g., StartingPoint).
- Experience with electronic document management systems (e.g., MasterControl, Documentum) preferred.
- Strong verbal, written, and interpersonal communication skills.
The Principal Medical Writer's responsibilities will be:
- Lead and coordinate all writing activities for regulatory submissions globally.
- Oversee and manage internal and contract medical writing resources to ensure timely project completion.
- Develop regulatory documents in accordance with ICH and global guidelines, standards, and processes.
- Participate in study and project team meetings to provide input on medical writing deliverables and timelines.
- Manage the receipt, collation, and incorporation of review comments for regulatory documents.
- Define and write standard operating procedures and working practices for quality document preparation.
- Participate in cross-functional process improvement initiatives.
- Mentor junior medical writing staff.
If you are having difficulty in applying or if you have any questions, please contact Mike Raletz at m.raletz@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
