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
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