Senior Medical Writer
Tubulis GmbH
full-time
Posted on:
Location Type: Remote
Location: Germany
Visit company websiteExplore more
Job Level
About the role
- Support the development of high-quality clinical and regulatory documents that support drug development programs
- Lead the medical writing of critical clinical and regulatory documents from start to finish
- Collaborate with internal teams and external vendors to effectively and proactively manage timelines and deliverables
- Provide input on document planning and regulatory submissions
- Ensure documents comply with ICH guidelines, regulatory requirements, and company standards
- Develop and maintain templates, style guides, and best practices for medical writing
Requirements
- Advanced degree in life sciences (PhD, PharmD, or MS preferred)
- 3-5 years of medical writing experience in the biotech/pharmaceutical industry
- Experience with regulatory submissions
- Prior involvement in NDA/BLA submissions is a strong plus
- Strong knowledge of ICH, FDA, and EMA guidelines
- Excellent writing, editing, and project management skills
- Experience in oncology therapeutic area
- Strong ability to work collaboratively and coordinate efforts to resolve comments with team members
- Experience with StartingPoint templates, PleaseReview, and Microsoft Project is a plus
- Ability to work independently in a fast-paced and dynamic, start-up environment
- Flexible and able to adapt to changing deadlines and manage multiple priorities
- High attention to detail
- Excellent organizational, communication, and problem-solving skills
Benefits
- Contribute to breakthrough therapies
- Work in an international, diverse team
- Develop your career in a supportive, fast-moving environment
- Push boundaries with cutting-edge science
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
medical writingregulatory submissionsNDA submissionsBLA submissionsICH guidelinesFDA guidelinesEMA guidelinesoncologyproject management
Soft skills
collaborationcommunicationproblem-solvingorganizational skillsattention to detailflexibilityindependencetime management
Certifications
PhDPharmDMS