Senior/Principal Medical Writer

Senior/Principal Medical Writer

ProductLife Group

Denmark, Norway or Sweden

In this role, you will work as a consultant to support our clients in the Pharma, Biotech and Medical Device industries. You will work on-site at the client’s location or remote with the support of the rest of the Regulatory Affairs & Medical Writing team as well as other experts within Pharma IT and PLG, when you need it.

As a Medical Writer Consultant, you will:

• Write and review clinical (and nonclinical) documents for regulatory submissions in the EU and US, such as Module 2.5, 2.7, 2.4, 2.6, integrated summaries of efficacy/safety, clinical trial protocols and reports, Paediatric Investigational plans, Orphan Drug Designation applications, Investigator’s Brochure, meeting requests and briefing documents, and other related documents as requested by our clients;
• Participate in answering questions from Health Authorities world-wide;
• Write and review scientific publications and scientific presentations;
• Collaborate with cross-functional teams, including external stakeholders, to ensure project goals, deliverables, and requirements;
• Foster effective communication and collaboration among project team members, ensuring clarity of roles and responsibilities;
• Ensure compliance with regulatory requirements and industry standards throughout the project lifecycle;
• Evaluate project outcomes and provide recommendations for process improvements and best practices.

The ideal candidate for this position holds the following qualifications:

• Graduate (PhD, MSc., M Pharm, Pharm D, or equivalent);
• 10+ years of experience within drug development in the pharma/biotech industry with at least 5 years experience with medical writing;
• Understanding of international regulations, ICH guidelines etc. related to document preparation and production (CTDs);
• Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products;
• Excellent leadership and interpersonal skills, with the ability to collaborate effectively with multidisciplinary teams;
• Exceptional problem-solving and decision-making abilities, with a focus on achieving results;
• Excellent written and verbal communication skills in English, with the ability to present complex information to diverse audiences;
• Frequent travel to Copenhagen.

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