Senior Medical Writer
The Senior Medical Writer is a newly created position here at Constellation. The primary deliverables for this role are writing clinical regulatory documents according to applicable regulations. We are #BrighterTogether.
How you will spend your day:
- Support development of oncology compounds by providing medical writing expertise to cross-functional project teams
- Lead development of high-quality, logical, accurate clinical, regulatory, and pharmacovigilance documents (clinical study protocols and amendments, study reports, investigator’s brochures, safety reports, briefing packages, clinical summary documents) under tight timelines and with minimal oversight
- Review study-related and regulatory documentation for consistency in presentation and messaging across a clinical development program
Key things about you:
- BS required, advanced degree in scientific discipline preferred
- At least 5 years in medical writing with experience in oncology, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
- Experienced in the preparation of clinical, regulatory, and pharmacovigilance documents
- Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
- Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high-quality documents according to tight timelines
- Wide knowledge of development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
- Independently motivated and good problem-solving abilities
- Ability to think strategically to further project and departmental development
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at email@example.com
Constellation Pharmaceuticals recognizes the value of diversity in our workforce. We are committed to equal opportunity. We consider all qualified employment applicants without regard to race, religion, color, gender, age, national origin, sexual orientation, gender identity, partnership status, protected veteran status, disability, or any other status protected by federal, state, or local law. Individuals who hold legal work authorization applicable to employment at Constellation Pharmaceuticals in the United States will be considered without regard to citizenship/alienage. Constellation Pharmaceuticals is a participant in E-Verify.
We are not accepting unsolicited resumes from employment agencies for any employment opportunities at this time.