This Job Vacancy has Expired!

Senior Medical Writer


Posted on Mar 14, 2023 by Actalent

London, United Kingdom
Immediate Start
Hourly Salary

Associate Principal Regulatory Writer

Contract - 6/12 months

Location - Fully remote (EU)

Salary - €70-90/hour (Outside IR35 UK)

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The APRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery



  • Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
  • Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
  • Author documents per client specifications, templates, style guides, and other guidance documents
  • Author documents per regulatory authority guidelines and requirements.
  • Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
  • Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
  • Manage budget for a low complexity project, including all contributors (writers, editors)
  • Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
  • Maintain collaborative, proactive, and effective communication with both client and internal teams
  • Lead project-related meetings and teleconferences
  • Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements


  • Bachelor's degree; MSc or PhD preferred
  • 8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as:

2.5 Clinical Overview

2.7 Clinical Summaries

Clinical Study Reports

Clinical Study Protocols

Briefing Documents

  • Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
  • Experience in the development of submission-level documents (does not require functioning as a document lead)

To find out more contact me via (see below)

Job Title: Senior Medical Writer

Location: London, UK

Job Type: Contract

Trading as Aerotek. Allegis Group Limited. No Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 2510806973


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