Lead Medical Writer (m|f|d) at Miltenyi Biotec

Bergisch Gladbach, North Rhine-Westphalia, Germany -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Writing, Regulatory Writing, Project Management, Leadership, Clinical Development, ICH Guidelines, Data Protection Laws, Oncology, Hematology, ATMPs, CAR-T Treatments, Mentoring, Team Management, Document Oversight, Cross-Functional Collaboration, Scientific Communication

Industry

Biotechnology Research

Description

Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR-T cell product, is currently undergoing pivotal clinical trials on a global scale. Join our highly professional team in bringing new medicines to the market. Job Description As a Medical Writer you are part of our Miltenyi biomedicine business and within the Clinical Development team. You will be responsible for the development and oversight of clinical and regulatory documents that support global drug development programs, including preparation, development, review, revision and finalization of clinical documents for submission to regulatory authorities. You lead the development, authoring, and submission of regulatory documents (e.g., CTD modules, clinical study reports, investigator brochures, INDs/IMPDs, NDAs/MAAs, and briefing documents). Your responsibility includes ensuring that all documents are scientifically sound, strategically aligned, and compliant with global regulatory standards. In addition, you manage document timelines, coordinate internal reviews, and ensure on-time delivery. Collaborating closely within cross-functional teams (clinical, regulatory, biostatistics, safety), you drive consistency and alignment across all deliverables and contribute to overall project success. You are actively leading technically Medical Writers, potentially participate in recruiting and onboarding junior writers, providing guidance and reviewing documents prepared by internal teams or external vendors to ensure quality and regulatory compliance. Qualifications You hold a degree in life sciences (or equivalent); an advanced degree (e.g., PhD or Master's) is preferred, and you bring proven experience in medical writing within clinical development with a strong focus on regulatory writing. As an expert in your field, you possess in-depth knowledge of ICH guidelines and data protection laws relevant to medical writing and you are experienced in setting up standards and processes. You have a strong track record of authoring and managing key regulatory submission documents; experience with MAA/BLA submissions is a plus. Experience with ATMPs/CAR-T treatments, oncology/hematology or autoimmune diseases is a plus. You demonstrate leadership through mentoring and managing small teams, ensuring high-quality deliverables. Your profile is rounded by a solid understanding of drug development and regulatory frameworks (ICH, EMA, FDA), excellent project management skills, and the ability to communicate complex scientific data clearly in English. Additional Information What we offer Working with free and self-determined time management, also mobile working An intercultural environment characterized by diversity and flat hierarchies Freedom to contribute creatively and play an active role in shaping the company Individual further training in our Miltenyi University as the core of the Miltenyi DNA 30 days of vacation, discounted ticket to Germany, (e)-bike leasing, capital-forming benefits, company pension plan, disability insurance, canteen, and much more. Diversity is the bedrock of our creativity Our mission: To innovate treatments and technologies and tackle the world’s most serious health challenges. And that’s why we connect the dots –across various disciplines, linking different perspectives, skills, and abilities. You and your talent are welcome here in our inclusive and collaborative environment. So come as you are. Regardless of gender, sexual identity, age, ethnicity, religion or disability. Become part of our team and focus on pushing the borders of medicine. We look forward to your application If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.

Responsibilities

You will be responsible for the development and oversight of clinical and regulatory documents that support global drug development programs. This includes leading the development, authoring, and submission of regulatory documents and ensuring compliance with global regulatory standards.