At a Glance
- Tasks: Lead and deliver high-quality medical writing for complex clinical and regulatory projects.
- Company: Join ViiV Healthcare, a leader in uniting science and technology to combat disease.
- Benefits: Visible impact, professional growth, and meaningful work aligned with GSK’s mission.
- Other info: Work in a multicultural team and enjoy opportunities for continuous learning.
- Why this job: Make a real difference in healthcare while advancing your career in a dynamic environment.
- Qualifications: Bachelor’s degree in life sciences and 5+ years of medical writing experience required.
The predicted salary is between 70000 - 90000 £ per year.
Vii V Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality medical writing for complex clinical and regulatory projects.
You will work closely with clinical, regulatory, statistical, and cross‑functional teams.
This role offers visible impact, professional growth, and meaningful work that aligns with GSK’s mission of uniting science, technology, and talent to get ahead of disease together.
Responsibilities
- Lead authoring and strategic planning for clinical and regulatory documents, including protocols, clinical study reports, briefing documents, and submission dossiers.
- Manage end‑to‑end writing projects, coordinating contributors, timelines, and quality checks to meet regulatory and internal standards.
- Translate complex clinical and statistical data into clear, accurate, and well‑structured scientific narratives for diverse audiences.
- Act as a subject matter expert on medical writing standards, document structure, and regulatory expectations.
- Drive process improvement initiatives, support KPI tracking, and contribute to audit readiness and compliance activities.
- Basic Qualifications
- Bachelor’s degree in life sciences, health sciences, or a scientific field.
- 5+ years of experience in medical or regulatory writing within the pharmaceutical or healthcare industry.
- 3+ years of experience with regulatory dossier development and Common Technical Document (CTD) module documents.
- 3+ years of experience independently authoring clinical protocols, clinical study reports, and regulatory submission documents.
- Preferred Qualifications
- Advanced degree (e. g., Ph D, Pharm D, MPH, MS) in life sciences or a related field.
- Experience leading regulatory submission projects, including Common Technical Document (CTD) dossiers.
- Familiarity with statistical concepts and ability to interpret clinical data.
- Strong problem‑solving skills and ability to adapt to changing priorities.
- Experience working in multicultural or remote team settings.
- Proven ability to independently write and manage complex regulatory documents.
- Strong understanding of International Council for Harmonisation (ICH) guidelines and Good Clinical Practice (GCP).
- Excellent written and verbal communication skills, with attention to detail.
- Experience managing multiple projects and meeting deadlines in a fast‑paced environment.
GSK is an Equal Opportunity Employer.
This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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Principal Medical Writer employer: Gsk
GSK is an exceptional employer located in Greater London, offering a dynamic and inclusive work environment that fosters innovation and collaboration. As a Senior FinOps Product Manager, you will have the opportunity to drive impactful projects while benefiting from robust employee growth opportunities and a culture that values diverse perspectives. With a commitment to professional development and a focus on agile methodologies, GSK empowers its employees to thrive in their careers while contributing to meaningful advancements in cloud financial management.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Medical Writer
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Gsk is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Principal Medical Writer
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Gsk!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Gsk that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Gsk!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Gsk, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Gsk
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Gsk that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Gsk’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
