Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead the creation of essential clinical regulatory documents and manage project timelines.
- Company: Join a dynamic team at Trilogy, dedicated to impactful medical writing.
- Benefits: Enjoy flexible work options, competitive pay, and opportunities for professional growth.
- Why this job: Make a difference in healthcare while collaborating with diverse teams and clients.
- Qualifications: 3+ years of regulatory writing experience and a degree in science or pharmacy required.
- Other info: Fluency in English and strong interpersonal skills are essential for success.
The predicted salary is between 43200 - 72000 £ per year.
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 Trilogy as well as the company’s 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.
Senior Medical Writer employer: Life Sciences Recruitment
Contact Detail:
Life Sciences Recruitment Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Make sure to highlight your experience with regulatory documents in your conversations. When networking or during interviews, emphasize specific projects where you were the lead writer and discuss the impact of your work.
✨Tip Number 2
Familiarize yourself with the latest trends and regulations in clinical writing. Being knowledgeable about current guidelines will not only help you in discussions but also show your commitment to staying updated in the field.
✨Tip Number 3
Demonstrate your project management skills by discussing how you've successfully managed timelines and budgets in past roles. Prepare examples that showcase your ability to coordinate with multiple stakeholders effectively.
✨Tip Number 4
Engage with professionals in the medical writing community through online forums or local meetups. Building connections can provide valuable insights and potentially lead to referrals for job openings at StudySmarter.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Highlight Relevant Experience: Make sure to emphasize your experience in writing clinical regulatory documents. Clearly outline the specific types of documents you've worked on and your role as a lead writer.
Showcase Project Management Skills: Demonstrate your ability to manage timelines and coordinate with other writers and clients. Provide examples of how you've successfully overseen projects and met deadlines.
Detail Your Educational Background: Include your degree in science or pharmacy, and any relevant certifications. This will help establish your qualifications for the role.
Express Interpersonal Skills: Since the role requires excellent interpersonal skills, mention any experiences where you effectively collaborated with diverse teams or interacted with clients. This will show that you can thrive in a team environment.
How to prepare for a job interview at Life Sciences Recruitment
✨Showcase Your Writing Experience
Be prepared to discuss your specific experiences as a lead writer on clinical regulatory documents. Highlight at least three examples of Clinical Study Protocols or Clinical Study Reports you've authored, and be ready to explain your role in the writing process.
✨Demonstrate Project Management Skills
Since project management is key for this role, share examples of how you've managed timelines and coordinated review cycles in previous projects. Discuss any tools or systems you used to keep everything on track.
✨Highlight Client Interaction Experience
Emphasize your experience interacting with clients or authors. Prepare to discuss how you’ve handled feedback and coordinated meetings, showcasing your interpersonal skills and ability to work with diverse teams.
✨Prepare for Technical Questions
Expect questions about document management systems and review tools. Brush up on your knowledge of relevant SOPs and the CTD format, as well as any specific regulations that may apply to the documents you'll be working on.
