At a Glance
- Tasks: Lead the creation of high-quality clinical and regulatory documents in a global team.
- Company: Join a leading global pharmaceutical organisation with a focus on innovation.
- Benefits: Long-term contract opportunity with a respected company and potential for career growth.
- Other info: Collaborate with experts and manage multiple projects in a dynamic environment.
- Why this job: Make a real impact in healthcare by ensuring safety and compliance in medical writing.
- Qualifications: Experience in medical writing, especially with clinical protocols and safety reports.
Your new company
Are you an experienced Senior Medical Writer looking for your next long-term contract opportunity? I am currently partnering with a leading global pharmaceutical organisation seeking a Senior Medical Writer to join their clinical and regulatory writing team on an initial 12-month contract. This role sits within a high-performing global team and will suit a writer who is confident leading the development of complex regulatory and safety documentation whilst collaborating with cross-functional stakeholders across Clinical Development, Pharmacovigilance, Regulatory Affairs, Biostatistics and Medical Affairs.
Your new role
- Lead the preparation, review and delivery of high-quality clinical and regulatory documents.
- Author and coordinate clinical study protocols and protocol amendments.
- Develop Pharmacovigilance and aggregate safety reports including:
- DSURs (Development Safety Update Reports)
- PBRERs (Periodic Benefit-Risk Evaluation Reports)
- Prepare clinical study reports, investigator brochures and other regulatory submissions as required.
- Support documentation associated with medical devices and combination products, ensuring compliance with relevant regulatory requirements.
- Collaborate with subject-matter experts to ensure scientific accuracy, consistency and timely delivery of documents.
- Drive document strategy, standards and quality across multiple development programmes.
- Ensure all documents meet global regulatory guidelines and company standards.
What you'll need to succeed
- Significant experience working as a Medical Writer within the pharmaceutical, biotechnology, CRO or medical device sector.
- Demonstrable experience authoring clinical study protocols.
- Strong experience writing DSURs and PBRERs.
- Medical device and/or combination product documentation experience.
- Excellent understanding of regulatory requirements and industry guidelines, especially GVP.
- Experience managing multiple deliverables across complex development programmes.
- Strong stakeholder management and communication skills.
- Degree qualified in a life sciences discipline (advanced degree advantageous).
What you need to do now
If you are a Senior Medical Writer with strong protocol, DSUR, PBRER and medical device experience and are looking for a long-term contract with a highly respected pharmaceutical company, I’d be delighted to discuss the opportunity with you.
Click 'apply now' to forward an up-to-date copy of your CV, or call Roberta Atkins on (phone number removed).
Before you apply for this position, it is vital that you are in possession of a UK passport or relevant visa to work without restrictions in the UK and must be based in the UK.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Medical Writer, Pharmacovigilance
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Hays Life Sciences.
We think you need these skills to ace Senior Medical Writer, Pharmacovigilance
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Hays Life Sciences.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Hays Life Sciences. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Hays Life Sciences
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Hays Life Sciences.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Hays Life Sciences achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
