Medical Writer - Regulatory Affairs

Southwood Research, a ProPharma Group company, is a leading provider of pre-approval regulatory science services to the pharmaceutical and biotech industries.

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group’s fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today’s dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

A Medical Writer will author regulatory, clinical trial, and medical affairs documentation, such as Module 2, CSRs, Investigative Brochures, Protocols, PIPs, Scientific Advice, and others. Additionally, the Medical Writer will contribute to medical writing knowledge to new business proposals.

Essential Functions Include:

• High-quality regulatory writing including authoring clinical summaries, briefing documents, and Paediatric Investigation Plans for EMEA submissions such as Module 2, CSRs, Investigative Brochures, Protocols, PIPs, Scientific Advice, and others.
• Represent Medical Writing on project teams and, as such, advise teams and clients on content and format requirements for various documents, as well as coordinate writing activities for document development.
• Ensure compliance, remain informed on regulations and developments in medical writing.
• Maintain knowledge of product areas, current trends, and current literature.
• Providing general scientific insight for new business pitches and proposals.

Qualified candidates must have:

• Post graduate degree in a life sciences discipline
• 5+ years experience in regulatory medical writing
• Regulatory and EMEA submission experience
• Good working knowledge of the healthcare and pharmaceutical industry
• Oncology, haematology, orphan diseases and immunology experience preferred
• Excellent interpersonal skills
• Keen attention to detail
• Flexibility to move quickly between projects and work across different therapy areas
• A positive can-do attitude
• Ability to work independently but contribute pro-actively to a project team

All candidates must be legally eligible to work in the United Kingdom.

 Some international travel may be required.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***