Senior/Principal Medical Writer

Product Life Group

10+ years

Not Disclosed

Denmark Norway

10 March 26, 2025

Job Description

Job Type: Full Time Education: M.Sc./M.Pharm/PhD/PharmD Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior/Principal Medical Writer – PLG Group
Location: Denmark, Norway, Sweden (Onsite and Offsite)
Category: Biopharmaceutical Drug Development Services, Product Development
Contract Type: Permanent

Role Overview:
Pharma IT, a PLG Group Company, is seeking experienced Senior/Principal Medical Writer Consultants to join the Regulatory Affairs & Medical Writing Team. You will work as a consultant supporting clients in the Pharma, Biotech, and Medical Device industries, either onsite at the client’s location or remotely, with support from Pharma IT and PLG experts when needed.

Key Responsibilities:

Medical Writing:

Write and review clinical and nonclinical documents for regulatory submissions in the EU and US, including:
- 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
Answer queries from Health Authorities worldwide.
Write and review scientific publications and scientific presentations.

Collaboration and Compliance:

Collaborate with cross-functional teams, including external stakeholders, to ensure project goals and deliverables are met.
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.

Evaluation and Improvement:

Evaluate project outcomes and provide recommendations for process improvements and best practices.

Candidate Requirements:

Education: PhD, MSc, M Pharm, Pharm D, or equivalent.
Experience:
- 10+ years of experience in drug development within the pharma/biotech industry.
- Minimum 5 years of medical writing experience.
- Strong understanding of international regulations, ICH guidelines, and document preparation for CTDs.
- Understanding of clinical development phases, processes, and techniques, from protocol design to regulatory submission and post-marketing support.
Skills:
- Excellent leadership and interpersonal skills to collaborate effectively with multidisciplinary teams.
- Strong problem-solving and decision-making abilities with a results-oriented mindset.
- Exceptional written and verbal communication skills in English.
- Ability to present complex information to diverse audiences.

Travel Requirement:

Frequent travel to Copenhagen is expected.

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Senior/Principal Medical Writer

Job Description

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