About The Position
You will lead medical writing for one or more development oncology assets, with accountability for asset-level medical writing strategy from planning to delivery. This is a highly visible, strategic role, partnering closely with Clinical Development, Regulatory Affairs, Biostatistics, Safety, and other functions in a matrix environment to shape regulatory strategy and deliver clear, high-quality, fit for purpose clinical documents for global regulatory interactions and submissions. You will balance scientific rigor with practical execution, champion efficient and accelerated ways of working, and proactively identify opportunities to simplify document lifecycle, reduce risk and strengthen submission quality across the asset lifecycle. We value collaborative leaders who apply sound judgement, practical problem solving and inclusive coaching to enable high-performing teams and successful outcomes. This role offers meaningful impact, visible growth opportunities, and a chance to unite science, technology and talent to get ahead of disease together.
Requirements
- Postgraduate degree e.g. PhD, PharmD, MSc, MPH, in life sciences, pharmacy, medicine, public health or related discipline
- Significant experience in clinical regulatory medical writing within the pharmaceutical or biotech industry
- Experience in authoring and leading regulatory clinical documents for global oncology FDA and/or EMA submissions
- Experience in leading multi-disciplinary, matrix teams and managing external medical writing vendors
- Experience in program management i.e. project planning and delivery skills, including risk identification and timeline management
- Written and verbal communication skills with the ability to present complex scientific content clearly.
Nice To Haves
- Experience delivering complex and accelerated submissions to major health authorities across regions
- Experience coaching, mentoring and developing training materials
- Familiarity with global regulatory guidelines and Good Clinical Practice principles
- Experience implementing medical writing technologies and process improvements
- Experience working across multiple locations in a matrix organization.
Responsibilities
- Lead strategy, planning, authoring and delivery of clinical documents across the asset lifecycle, including clinical study protocols, clinical sections of the IMPD/IND, investigator brochures, clinical study reports, briefing documents for regulatory authorities, Common Technical Document Summaries and Clinical Overview, and responses to regulatory authority questions.
- Own and drive asset-level medical writing strategy, ensuring alignment with development and regulatory objectives across regions
- Lead and coach multi-disciplinary matrix teams and external vendors to meet quality, timeline and budget expectations.
- Plan and deliver complex and accelerated global submissions, recommending innovative approaches to achieve ambitious timelines while proactively managing cross-functional interdependencies and risks.
- Create and maintain submission and document lifecycle plans. Advise teams on fit-for-purpose approaches and risk mitigation.
- Act as lead author or senior reviewer for complex submission documents and regulator queries, ensuring clear scientific positioning and compelling regulatory narratives.
- Define and recommend resourcing strategies for major projects, including optimal use of internal teams and external vendors
- Drive process and technology improvements that increase consistency, efficiency and document quality while constructively challenging the status quo.
- Mentor colleagues and build oncology medical writing capability through training, clear feedback and practical guidance, including contribution to training materials.
- We welcome applicants who value clear communication, collaboration and practical leadership.
Benefits
- All statutory benefits will be maintained in accordance with Polish law.
- Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave.
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
5,001-10,000 employees
