Lead Medical Writer (m|f|d)

Miltenyi Biomedicine; Bergisch Gladbach; Hybrid; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A biopharmaceutical company in Nordrhein-Westfalen is seeking a Medical Writer to develop and oversee clinical and regulatory documents. The role involves leading submissions, managing timelines, and mentoring junior writers within a collaborative team. Candidates should have a background in life sciences with a strong focus on medical writing and regulatory compliance. The company offers a creative and supportive environment with diverse benefits including flexible working and substantial vacation.

Leistungen

30 days of vacation

Discounted ticket to Germany

(e)-bike leasing

Company pension plan

Canteen

Qualifikationen

• Proven experience in medical writing within clinical development.
• In-depth knowledge of ICH guidelines and data protection laws.
• Experience with MAA/BLA submissions is a plus.

Aufgaben

• Lead the development and submission of regulatory documents.
• Ensure all documents are compliant with regulatory standards.
• Collaborate within cross-functional teams for project success.

Kenntnisse

Medical writing

Regulatory writing

Project management

Team leadership

Communication of scientific data

Ausbildung

Degree in life sciences

PhD or Master's preferred

Jobbeschreibung

Overview

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.

Responsibilities

• 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.

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 and inclusion

Diversity is the bedrock of our creativity. Our mission is to innovate treatments and technologies and tackle the world’s most serious health challenges. 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.