At a Glance
- Tasks: Lead medical writing projects, ensuring clarity and accuracy in scientific documents.
- Company: Join Syneos Health, a top biopharmaceutical solutions organisation focused on customer success.
- Benefits: Enjoy health benefits, flexible PTO, and a supportive work-life balance.
- Other info: Mentorship opportunities and a commitment to diversity and inclusion.
- Why this job: Make a real impact in the biopharmaceutical field while collaborating with passionate professionals.
- Qualifications: 5+ years of regulatory writing experience and strong project management skills.
The predicted salary is between 55000 - 70000 £ per year.
About Syneos Health Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
Job Responsibilities
- Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
- Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
- Completes a variety of documents that may include clinical study protocols, clinical study reports (CSRs), patient narratives, investigator brochures (IBs), informed consents, annual reports, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, and NDA/eCTD submissions.
- Adheres to established regulatory standards, including ICH E3 guidelines, company SOPs, and client‑approved templates.
- Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.
- Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
- Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, and format.
- Interacts and builds good working relations with clients and peers in data management, biostatistics, regulatory affairs, and medical affairs.
- Mentors and leads less experienced medical writers on complex projects.
- Develops deep expertise on regulatory requirements and guidelines that affect medical writing.
Qualifications
- Minimum of 5 years of lead regulatory writing experience.
- Experience with Phase 2 and 3 clinical trials.
- Lead writer experience with protocols, submissions, clinical Summary of Safety (CTD) Modules 2.7.3 and 2.7.4, CSRs, IBs, Patient Narratives, Safety Aggregate Reports, Briefing books, ISE and ISS.
- Strong project management and client‑facing experience.
- Excellent time management skills.
- Process experience is a significant advantage.
Benefits
We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include health benefits (Medical, Dental, and Vision), company match pension/401k, eligibility to participate in Employee Stock Purchase Plan, and flexible paid time off (PTO). Syneos Health is an equal opportunity employer committed to diversity and inclusion in the workplace.
Senior / Principal Medical Writer (Regulatory) United Kingdom employer: Meeveem Limited
At Syneos Health, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through mentorship opportunities and a focus on professional development, all while offering competitive benefits such as health coverage, a pension plan, and flexible paid time off. Located in the United Kingdom, our team of passionate problem solvers works together to make a meaningful impact in the biopharmaceutical industry, ensuring that every employee feels valued and empowered to contribute to our customers' success.
StudySmarter Expert Advice🤫
We think this is how you could land Senior / Principal Medical Writer (Regulatory) United Kingdom
✨Get Involved in Local Research Communities
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We think you need these skills to ace Senior / Principal Medical Writer (Regulatory) United Kingdom
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Meeveem Limited that you have the hands-on skills they need.
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Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Meeveem Limited does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Meeveem Limited
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Meeveem Limited. You might even be asked to demonstrate your understanding of these processes.
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Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
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Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Meeveem Limited's culture.
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