Principal Medical Writer, Regulatory

4 days ago

London, United Kingdom Albion Rye Associates Full time

Principal Regulatory Writer / Head of Medical Writing London based (Hybrid working)
Albion Rye Associates have partnered exclusively with one of the largest and most comprehensive providers of drug development and regulatory science services. You will be working on key drug development projects for biopharmaceutical companies and making a change in helping critical drug products get to patients.

Prepare high-quality documentation for regulatory submissions
Author documents per client specifications and regulatory authority guidelines and requirements
Project leader - actively participate, develop and write high-quality documents
Work closely with clients, and internal and partner teams to lead the development of strategy and prepare regulatory documentation.
Manage budgets, projects and team
Mentor junior members in the knowledge of authoring regulatory documents and complying with SOPs and training requirements

Oncology, Neuroscience, Dermatology, Diabetes, Respiratory, Ophthalmology, CNS, Cardiovascular, Cardiology, Immunology, Rare Disease, Haematology, Infectious Disease, Vaccines, Virology, Biology, Auto-immune disease, Neurology, Orthopaedics, Gastroenterology, Endocrinology, Urology, Womens Health

7+ years of regulatory writing experience (ideally from a CRO or Consultancy)
~ Clinical Research experience
~ Full understanding of regulatory requirements across all phases of development and pathways
~ Competitive pay
Retirement plans
Wellness programmes
Unlimited paid time off
Employee assistance program

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