Job Title: Medical Writing Director
The role of the Medical Writing Director involves overseeing the preparation and delivery of high-quality, strategically aligned medical writing deliverables within one or more programs. This includes working directly with cross-functional teams to author regulatory documents such as protocols, clinical study reports, briefing books, submission documents, and investigator brochures.
The successful candidate will ensure that communication points are conveyed in medical writing deliverables and that these points are consistent across program documentation. They will also mitigate risk associated with medical writing and disclosure processes by contributing to Best Practices and SOPs.
• Works with cross-functional teams for effective communication of data in respective documents.• Ensures early consideration of communication needs for clinical data across program lifecycle.• Analyzes study level documents for their ability to deliver information required by target audience (e.g., health authorities).• Communicates proactively within MW team R&D.
Required Skills & Qualifications
The ideal candidate must have exceptional English language skills along with a clear understanding of lean authoring concepts. In addition they should possess expert MS Office skills particularly focusing on word processing tables spreadsheets presentations graphics templates.
(1) Clinical Regulatory Documents:&bR Experience is necessary - ICH CTD guidelines knowledge highly valued.
(3)Authoring Strategies:Able simplify complex information into user-friendly formats comprising protocol development technical operations training content strategy publication tactics.,