Senior Medical Writer

Talentmark are recruiting for a Regulatory Documentation Scientist (Senior Medical Writer) to join a company in the pharmaceutical industry on a contract basis for 12 months (outside IR35).

Salary:

Up to £56.40 per hour PAYE or £75 per hour via Umbrella/Ltd

Regulatory Documentation Scientist (Senior Medical Writer) Role:

• Lead cross-functional teams and Content Strategists in the development and execution of regulatory content strategies for submissions to global health authorities.
• Drive the interpretation of scientific and clinical data and develop high-quality regulatory documentation including clinical dossiers and safety reports.
• Review regulatory documents for clarity, scientific accuracy and consistency of messaging across complex submission packages.
• Collaborate with global stakeholders across regulatory, clinical and safety functions to resolve content issues and ensure compliance with regulatory requirements and internal processes.

• Degree in Life Sciences or a related discipline with significant experience in the pharmaceutical or biotechnology industry.
• Demonstrated experience in regulatory medical writing or documentation across clinical, safety or device submissions throughout the product lifecycle.
• Strong understanding of global drug and device development regulations and guidelines including GxP, GCP, ICH, ISO and MDR/IVDR.
• Experience contributing to global regulatory filings and collaborating within cross-functional project teams.

Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.

Location:

This is a remote role.

Apply:

For more information, or to apply for this Regulatory Documentation Scientist (Senior Medical Writer) role please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 177737.

It is essential that applicants hold entitlement to work in the UK.

Please note: This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.