Medical Writing Director
Pharmacosmos is seeking an experienced Medical Writing Director to provide strategic and hands-on medical writing support for our clinical development and marketed programs. You will play a key role in ensuring high-quality clinical documentation, regulatory compliance, and clear, patient-focused communication of clinical data across the organization.
As the subject matter expert for clinical and regulatory documentation, you will contribute to the planning, authoring, and review of key deliverables in close collaboration with Clinical Science, Biostatistics, Clinical Operations, Regulatory Affairs, and external partners. The role includes oversight of outsourced medical writing activities and responsibility for public disclosure of clinical trial information. The position carries no formal line management responsibilities.
Key Responsibilities
Medical Writing Leadership & Documentation: Own and lead medical writing for assigned clinical development programs, ensuring high-quality, compliant, and consistent clinical and regulatory documentation, including protocols, Clinical Study Reports (CSRs), Investigator’s Brochures (IBs), and clinical sections of regulatory submissions, in line with internal standards and best practices.
Vendor Management & Outsourcing: Oversee outsourced medical writing activities end-to-end, setting clear expectations and standards for Contract Research Organizations (CROs) and external writers, and ensuring timely, high-quality deliverables aligned with Pharmacosmos standards and program objectives.
Regulatory Support & Compliance: Support regulatory submissions and interactions by providing well-structured, compliant clinical content in alignment with ICH (International Council for Harmonisation) GCP (Good Clinical Practice) and Regulatory (European Medicines Agency/U.S. Food and Drug Administration) requirements and evolving guidance.
Public Disclosure & Transparency: Lead or oversee public disclosure of clinical trial information, including registry postings and document redaction, in close collaboration with Regulatory Affairs and Legal, ensuring consistency with source documents and global disclosure requirements.
Qualifications
MSc or PhD in Life Sciences, Pharmacy, Medicine, or a related discipline.
Minimum 8 years of experience in medical writing within pharma, biotech, or a CRO.
Strong experience with protocols, CSRs, IBs, and regulatory submissions across clinical development phases 1–4.
Experience with publication development and clinical trial disclosure.
Solid understanding of ICH/GCP and EMA/FDA requirements.
Excellent scientific writing and analytical skills, with a structured and proactive approach to managing multiple projects and deadlines.
Strong collaboration and communication skills, high integrity, and a patient-centric mindset.
What We Offer
A key role in shaping medical writing excellence, documentation quality, and regulatory compliance in a growing organization.
A friendly and supportive team culture with close collaboration across Clinical Science, Regulatory Affairs, and other key functions.
The opportunity to contribute to efficient, data-driven, and transparent clinical documentation, including public disclosure and evolving regulatory standards.
A flexible hybrid working model and a competitive compensation package reflecting the senior expertise of the role.
Join Us
If you are motivated by scientific quality, collaboration, and the opportunity to make a meaningful impact on patient care worldwide, we would love to hear from you.
We review applications and conduct interviews on an ongoing basis, so we encourage you to apply as soon as possible. If you have any questions about the position, please feel free to contact Head of Clinical Science, Thomas Delvin, at +45 3127 2206.
About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, the USA, and China. Learn more about Pharmacosmos at www.pharmacosmos.com.