Senior Medical Content Specialist
3 weeks ago
Proclinical Staffing is seeking a highly skilled Principal Medical Writer to lead our medical writing team. As a key member of our team, you will be responsible for developing high-quality clinical documents for global regulatory submissions.
Key Responsibilities:- 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.
- 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.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. We are an equal opportunity employer.
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