At a Glance
- Tasks: Write and coordinate complex clinical documents independently while collaborating with diverse teams.
- Company: Join a leading pharmaceutical company committed to innovation and inclusion.
- Benefits: Gain exposure to global teams, continuous learning, and opportunities for career growth.
- Other info: Work in a respectful environment that values accountability and promotes professional development.
- Why this job: Make a real impact in drug development while enhancing your writing and collaboration skills.
- Qualifications: Up to 5 years of clinical regulatory writing experience and strong English language skills.
The predicted salary is between 50000 - 65000 £ per year.
Position Summary
The Senior Medical Writer is expected to work on assignments largely independently or for complex documents, under guidance of a mentor, facilitating delivery of the written assignments through proactive coordination of stakeholders to build content. The writer understands clinical trials design and interpretation of statistically analysed clinical research data. He/she would be expected to drive and coordinate the process to draft, review and approve written assignments and should be able to meet the quality standards of the global organization. The Medical Writer is responsible for the final deliverable and is expected to work in complex matrix organizations.
Key Responsibilities
- Completes assignments independently or for more complex documents, under guidance of a mentor
- Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
- Ensures high integrity of data interpretation, following negotiation with document team.
- Ensures the consistency and quality level of all documents that are issued.
- Actively participates in all planning, coordination and review meetings.
- Ability to work on 2-3 assignments simultaneously.
- Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
- Works directly with a diversity of roles at different levels within GSK (e.g., Clinical Leads, Asset Leads, Study Delivery Leads (SDL), Biostatisticians, other Medical Writers).
- Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.
Requirements
- Up to 5 years clinical regulatory writing experience in the pharmaceutical industry
- Possesses a good understanding of basic drug development
- Demonstrates knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research.
- Demonstrates understanding of how to interpret, describe and document clinical data.
- Possesses working knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP).
- Possesses necessary computer skills and general computer literacy.
- Excellent English language skills (verbal and written)
What we offer in the role
You will join a team that values respectful collaboration, continuous learning and accountability. You will gain exposure to global teams and complex clinical programs. You will have clear opportunities to broaden your technical skills and take on increasing responsibility.
As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.
Senior Medical Writer in Stevenage 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 Senior Medical Writer in Stevenage
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We think you need these skills to ace Senior Medical Writer in Stevenage
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.
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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.
