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- 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 competitive pay, flexible work options, 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 relevant degree required.
- Other info: Fluency in English and strong interpersonal skills are a must!
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, discuss specific projects where you were the lead writer and how you managed timelines and budgets.
✨Tip Number 2
Familiarize yourself with the document management systems commonly used in the industry. If you have experience with specific tools, be ready to discuss how you've utilized them to streamline your writing process.
✨Tip Number 3
Demonstrate your interpersonal skills by preparing examples of how you've successfully collaborated with clients and team members. Be ready to share instances where you coordinated review cycles or facilitated meetings effectively.
✨Tip Number 4
Stay updated on the latest trends and regulations in medical writing. Being knowledgeable about current practices will not only help you in interviews but also show your commitment to the field.
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 your role as a lead writer on the required documents, such as Clinical Study Protocols and Clinical Study Reports, to demonstrate your qualifications.
Showcase Project Management Skills: Detail your project management experience, including how you have managed timelines and budgets for document preparation. Mention any specific tools or systems you have used to coordinate review cycles and client interactions.
Demonstrate Attention to Detail: Since the role requires an appreciation for well-written documents, provide examples of how your attention to detail has positively impacted your previous work. This could include instances where your thoroughness improved document quality or compliance.
Tailor Your Application: Customize your CV and cover letter to align with the job description. Use keywords from the job posting to ensure your application resonates with the hiring team and highlights your fit for the Senior Medical Writer position.
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 key projects where you played a significant role, detailing the types of documents you produced and the impact they had.
✨Demonstrate Project Management Skills
Since project management is crucial for this role, come ready to share examples of how you've managed timelines and coordinated review cycles in past projects. Discuss any tools or systems you used to keep everything on track.
✨Highlight Client Interaction Experience
Prepare to talk about your experience interacting with clients or authors. Share specific instances where you successfully coordinated meetings or navigated feedback, showcasing your interpersonal skills and ability to work with diverse teams.
✨Emphasize Attention to Detail
Given the importance of detail in medical writing, be ready to discuss how you ensure accuracy and quality in your documents. You might want to mention any specific strategies or checklists you use to maintain high standards.
