Senior Medical Writer

Currently looking to hire Senior/Principal Medical Writers for our UK team, to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. You will be part of a team that provides a service that goes beyond just writing. Our writers are integral parts of clinical development teams supporting the writing and coordinating of successful documentation across a broad spectrum of therapeutic areas. As a growing company, there is room to develop with us and your ideas will form our future together.

As a Senior/Principal Medical Writer, you will:

• Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
• Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of our clients.
• Be responsible for providing document-specific advice to clients.
• Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
• Project manage the timelines and review cycles of your documents.
• Work in the client’s regulatory document management systems.

The candidate must have the following writing experience:

• At least 3 years of experience actively writing regulatory documents.
• Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs.
• For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier (e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC)).
• For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.
• Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
• Competency in the use of document management systems and review tools.

In addition to having the above writing experience, applicants must have:

• Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
• Fluent written and spoken English skills.
• An appreciation for a well-written document and an eye for detail.
• Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
• Flexibility and the ability to stay focused under tight timelines.

Only candidates who meet the following requirements will be considered:

• Candidate must live in one of the following countries: UK. Applicants will work fully remote, hybrid remote or can work in our office in Cambridge, UK. Freelancers need not apply.
• Submission of documents in English:
• Cover letter specifying how you comply with the experience requirements listed above
• CV

Skills

• Authoring
• Lead Authoring
• Medical writing
• Medical
• Written and communication skills
• Documentation writing
• Regulatory Writing
• Clinical
• Supporting author

Job Title: Senior Medical Writer

Location: London, UK

Rate/Salary: 35000.00 - 65000.00 GBP Yearly

Job Type: Permanent