Regulatory Documentation Specialist

13 hours ago


London, Greater London, United Kingdom Actalent Full time

We are seeking a highly skilled Regulatory Documentation Specialist to join our team in the UK. As a Senior Medical Writer, you will play a crucial role in producing high-quality regulatory documentation for the international pharmaceutical industry.

With a strong background in medical writing and a deep understanding of regulatory requirements, you will work closely with our clients to deliver exceptional results. Your expertise will ensure that all documents meet the highest standards, on time and within budget.

In this role, you will be responsible for:

  • Preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures;
  • Leading authoring teams to ensure timely delivery of high-quality documents;
  • Coordinating review cycles, meetings, and project timelines to meet client needs;
  • Providing document-specific advice to clients and ensuring compliance with relevant SOPs.

The ideal candidate will have:

  • A minimum of 3 years of experience in medical writing, with a focus on regulatory documentation;
  • A strong track record of delivering high-quality documents on time and within budget;
  • Excellent written and communication skills, with the ability to interact effectively with clients and authors;
  • Proficiency in using document management systems and review tools;
  • A Bachelor's degree in science or pharmacy, with a strong foundation in regulatory affairs.

This is an excellent opportunity to join a dynamic team and contribute to the success of our clients. If you are a motivated and experienced Regulatory Documentation Specialist looking for a new challenge, we encourage you to apply.



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