Manager Medical Writing

Meet Life Sciences; Köln; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading life sciences company in Köln is seeking an experienced Medical Writing Manager to oversee medical writing projects. Responsibilities include managing timelines, ensuring compliance with regulatory standards, and leading document development. The ideal candidate has 5-8 years of experience, a relevant degree, and excellent communication skills. This role offers the opportunity to collaborate with cross-functional teams in a dynamic environment.

Qualifikationen

• 5–8 years of medical writing and project management experience in the pharmaceutical or biotech industry.
• Proven experience in a senior medical writing role.
• Fluency in English, strong knowledge of scientific terminology and regulatory guidelines.

Aufgaben

• Oversee end-to-end management of medical writing projects.
• Lead the development of various regulatory and scientific documents.
• Coordinate with internal teams and external partners.

Kenntnisse

Medical writing expertise

Project management

Excellent communication skills

Regulatory knowledge

Ausbildung

Bachelor's degree in life sciences

Advanced degree (e.g. MSc, PhD)

Jobbeschreibung

We are seeking an experienced Medical Writing Manager / Lead to oversee the planning, coordination, and delivery of key regulatory and scientific documents. The role involves collaboration with cross-functional teams, management of multiple projects, and a focus on delivering high-quality, compliant documentation.

Main Responsibilities

• Oversee the end-to-end management of medical writing projects, including planning, timeline management, stakeholder coordination, and delivery of final documents.
• Lead the development of a range of documents, including protocol outlines, informed consent forms, clinical study reports, sections of Module 2 of the eCTD, patient-facing materials, lay summaries, registry content, publications, posters, and abstracts.
• Ensure all content is scientifically accurate, clear, and consistent, meeting regulatory and internal quality standards.
• Coordinate with internal teams (clinical, regulatory, biostatistics, data management, patient engagement, project management) and external partners (CROs, KOLs, patient advocacy groups) to gather input and ensure alignment on objectives.
• Conduct quality control checks for accuracy, grammar, formatting, and template compliance across all documents.
• Ensure all documentation complies with applicable regulatory guidelines and company SOPs, and support submission readiness.
• Contribute to process improvement initiatives, including the implementation of AI tools and digital repositories to enhance document development efficiency.
• Maintain accurate records of timelines, milestones, and deliverables, providing regular progress updates to stakeholders.
• Support training and mentoring of junior writers, promoting collaboration and continuous learning within the team.

Requirements

5–8 years of medical writing and project management experience in the pharmaceutical, biotech, or related industry.

Proven experience in a senior or principal medical writing role.

Bachelor's degree in life sciences, pharmacy, or a related field; an advanced degree (e.g. MSc, PhD) is preferred.

Fluency in English (spoken and written).

Strong knowledge of scientific and medical terminology, regulatory guidelines, and clinical trial processes.

Excellent project management, organizational, and communication skills.

Ability to work independently and collaboratively in a fast-paced, deadline-driven environment.

Experience mentoring junior team members is a plus.