Apply🧭 Full-Time
💸 200000.0 - 230000.0 USD per year
🔍 Pharmaceuticals
- S./B.A. degree required, advanced degree highly desirable.
- Minimum of 12 years of relevant medical writing experience in the pharmaceutical industry, focusing on ophthalmology or rare diseases.
- Understanding of the drug development process.
- Strong leadership and mentorship skills.
- Experience managing direct and indirect reports including medical writing contractors.
- Strong knowledge of clinical research concepts, practices, and FDA regulations.
- Ability to communicate effectively and manage project timelines.
- Coordinate and author clinical and regulatory documents to ensure integration of scientific and medical input from development team members.
- Lead submission-level documents at the project manager level and handle all components of writing clinical regulatory documents.
- Evaluate the consistency of style guide and scientific messaging across documents.
- Assure documents comply with ICH and regulatory guidelines.
- Represent medical writing at cross-functional meetings.
- Review and ensure consistency across all documents.
- Lead team review meetings and produce high-quality documentation.
- Oversee document preparation activities and ensure timely progress.
- Direct, train, and assist other medical writers.
Interpersonal skillsAdaptability
Posted 17 days ago
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