Medical Writing Operations Specialist
The Medical Writing Operations Specialist is a newly created position and will be responsible for ensuring production of the highest quality clinical, regulatory, and pharmacovigilance documents. This will include document quality review (including content, formatting, and document consistency), publishing, and archiving of medical writing documents according to quality standards and defined timelines. We are #BrighterTogether.
How you will spend your day:
- Provide technical editing and/or quality control checks on clinical, regulatory, and pharmacovigilance documents
- Ensure that clinical, regulatory, and pharmacovigilance documents are formatted correctly and are submission-ready
- Create, update, and maintain clinical, regulatory, and pharmacovigilance document templates
- Compile publications and references
- Work cross-functionally to prepare and publish clinical study report appendices
- Archive clinical, regulatory, and pharmacovigilance documents appropriately
Key things about you:
- Bachelor’s degree in a relevant field
- At least 3 years of experience with document QC and publishing in a pharmaceutical or biotech company or a CRO
- Knowledgeable about technical regulatory requirements for submissions
- Adept in MS Word and Adobe Acrobat and can teach others, willing to learn new software as needed
- Exposure to Starting Point templates, EndNote software, SharePoint, Veeva
- Well-organized: ability to prioritize tasks and to work simultaneously on multiple projects according to tight timelines
- Independently motivated and good problem-solving abilities
Don’t see the position you’re looking for? We want to hear from you regardless! Please submit your CV to us at firstname.lastname@example.org
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.