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Principal Medical Writer - Clinical & Regulatory

Employer
Albion Rye Associates
Location
London based (Hybrid working)
Salary
£75,000 - £90,000
Start date
22 Nov 2024
Closing date
22 Dec 2024
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Job Details

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

Company

At Albion Rye Associates, we create a bespoke recruitment process that is thorough, professional, personable – and most importantly, tailored to exactly to what you need.

We have a clear focus on collaboration and communication. We are solutions-led and know from vast experience that for successful outcomes to be reached, we don’t just work for our clients and candidates – we work with them.

Our valued clients and candidates have the highest of standards and expectations. We are exactly the same. If we weren’t, they wouldn’t want to work alongside us. We ensure that every client and candidate receives the made-to-measure, personalised recruitment service that they want, need, and deserve through building long-term working relationships.

Company info
Website
Telephone
02033079111
Location
Explorer 2, Second Floor
Fleming Way
Crawley
West Sussex
RH10 9GT
United Kingdom

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