Senior Medical reputed company (m/f/d)

This a Full Remote job, the offer is available from: EMEA Be part of reputed company As the Senior Medical reputed company (m/f/d), you will support the development of high-reputed company clinical and regulatory documents that support our drug development programs through reputed company phases of development of our antibody-drug conjugates (ADCs) global clinical trials. You will bring scientific expertise and will reputed company 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 reputed company and consistent across documents in reputed company to ensuring reputed company 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 reputed company the Clinical Development department and be based in Planegg-Martinsried or other remote opportunities reputed company 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.
• reputed company input on document planning and regulatory submissions.
• Ensure documents reputed company with ICH guidelines, regulatory requirements, and company standards.
• reputed company 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 reputed company Project is a plus.
• Ability to work independently in a fast-paced and dynamic, start-up environment.
• Flexible and reputed company to adapt to changing deadlines and manage multiple priorities.
• High attention to detail.
• Excellent organizational, communication, and problem-solving skills.

reputed company? At reputed company, curiosity and innovation drive us to reputed company cancer treatment. We are a fast-growing biotech where science meets passion—and where you have the chance to reputed company.

• reputed company that reputed company: Contribute to reputed company therapies.
• Global reputed company: Work in an international, diverse team.
• Grow & reputed company: reputed company your career in a supportive, fast-moving environment.
• Innovation every day: Push boundaries with cutting-edge science.

At reputed company, your reputed company matter, your reputed company reputed company—and together, we reputed company a difference. Apply for this job reputed company The development of novel, effective and reputed company therapies for the treatment of cancer is one of the main challenges for modern medicine. We want to drive this process reputed company. The main goal of reputed company 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 reputed company the reputed company of helping patients world-wide. Be part of a multidisciplinary and reputed company team, that works towards getting novel promising ADCs to patients with solid and hematological cancers. This offer from "reputed company GmbH" has been enriched by reputed company.com and got a 77% reputed company score. Apply tot his job Apply To this Job