Senior Medical Writer (m/f/d)
This a Full Remote job, the offer is available from: EMEA Be part of our team As the Senior Medical Writer (m/f/d), you will support the development of high-quality clinical and regulatory documents that support our drug development programs through all phases of development of our antibody-drug conjugates (ADCs) global clinical trials. You will bring scientific expertise and will lead the medical writing of critical clinical and regulatory documents from start to finish by working closely with Clinical Development, Regulatory Affairs, Biostatistics, and other key stakeholders. You will support cross-functional teams to ensure data presentation and messaging is clear and consistent across documents in addition to ensuring timely and compliant document delivery. You must have experience with leading the development of clinical and regulatory documents in collaboration with cross-functional teams in order to be successful in this role. This position will report to the Senior Vice President, Regulatory Affairs within the Clinical Development department and be based in Planegg-Martinsried or other remote opportunities within Germany. Your mission
- Author, review, and manage clinical and regulatory documents including:
- * Clinical Study Protocols and Amendments
- Investigator Brochures
- Clinical Study Reports (CSRs)
- Regulatory submission documents (e.g., INDs, NDAs, MAAs) and briefing documents
- Publications
- 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.
Your profile
- Advanced degree in life sciences (PhD, PharmD, or MS preferred) is required.
- 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.
Why us? At Tubulis, curiosity and innovation drive us to transform cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to grow with us.
- Impact that matters: Contribute to breakthrough therapies.
- Global mindset: Work in an international, diverse team.
- Grow & thrive: Develop your career in a supportive, fast-moving environment.
- Innovation every day: Push boundaries with cutting-edge science.
At Tubulis, your ideas matter, your growth matters—and together, we make a difference. Apply for this job About us The development of novel, effective and safe therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process forward. The main goal of Tubulis is to become a leading company in the field of targeted therapeutics and antibody-drug conjugates (ADCs). With a strong team, our own technologies and innovative therapeutic concepts, we are ushering in a new era in the ongoing fight against cancer and share the vision of helping patients world-wide. Be part of a multidisciplinary and focused team, that works towards getting novel promising ADCs to patients with solid and hematological cancers. This offer from "Tubulis GmbH" has been enriched by Jobgether.com and got a 77% flex score. Apply tot his job Apply To this Job