Principal Medical Writer

4 days ago

London, United Kingdom Albion Rye Associates Full time

Principal Regulatory Writer / Head of Medical Writing

London based (Hybrid working)

Salary up to 80,000 + Attractive benefits

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.

Responsibilities

  • 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
  • Act as subject matter expert and liaison internally and externally for clients
  • 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

Therapy areas covered: 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

Who you are:

  • BSc (Minimum)
  • 7+ years of regulatory writing experience (ideally from a CRO or Consultancy)
  • Clinical Research experience
  • Lead authorship experience
  • Leadership capabilities
  • Full understanding of regulatory requirements across all phases of development and pathways
  • Strong experience creating documents and of drug development lifestyle

Benefits:

  • Competitive pay
  • Incentives
  • Retirement plans
  • Income security programmes
  • Wellness programmes
  • Unlimited paid time off
  • Employee assistance program

Don't miss out on a great opportunity and contact me for a confidential conversation today - jake.byrne@albionryeassociates.com

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