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For Companies At a Glance
- Tasks: Create and manage clinical and regulatory documents for a leading pharma company.
- Company: Join a top-tier biotech firm making waves in the pharmaceutical industry.
- Benefits: Enjoy stable employment with opportunities for professional growth and collaboration.
- Why this job: Be part of impactful projects that shape healthcare while working in a dynamic environment.
- Qualifications: Bachelor's degree required; Master's preferred, with 3-5 years of relevant medical writing experience.
- Other info: Must have prior regulatory writing experience in a pharmaceutical setting.
The predicted salary is between 43200 - 72000 £ per year.
We are looking for experienced pharmaceutical Sr. Medical Writer. As a Senior Medical Writer, you will be supporting a Top-tier pharma company. You have the chance to help our customer deliver regulatory and submission documents. While being stably employed with us, you will be fully embedded with our client.
Main responsibilities:
- Independently produces clinical and regulatory documents in collaboration with Principal Medical Writers. These documents may include clinical study level documents such as clinical summary documents, protocols, CSRs, IBs, briefing books and response documents, PIPs. This includes Phase 1 in patients to Phase 3 across multiple therapeutic areas.
- Thoroughly analyse and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
- Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.
- Facilitates the review of the documents and ensures that documents are submission-ready and finally approved. When preparing documents, you will be directly in contact with QC personnel and publishing specialists who support you in document preparation.
Requirements:
- Minimum requirement of a bachelor’s degree; Master’s degree preferred.
- 3-5 years Medical Writing experience in relevant pharmaceutical companies combined with scientific and regulatory knowledge (a must).
- Strong writing skills and the ability to convert scientific data into clear, scientifically sound, well-structured messages.
- Proficient in independently writing several types of clinical/regulatory documents (protocols, CSRs, etc.) including leading creation, coordination of the authoring functions, facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved.
Please note that prior experience as a regulatory writer (min 3 years) in a pharmaceutical setting is mandatory and only profiles who match the criteria will be considered for the next steps.
Senior Medical Writer employer: Key Life Sciences
Contact Detail:
Key Life Sciences Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Network with professionals in the biotech and pharmaceutical industries. Attend relevant conferences, webinars, or local meetups to connect with others in the field. This can help you learn about job openings and get referrals.
✨Tip Number 2
Join online forums and groups focused on medical writing and regulatory affairs. Engaging in discussions can provide insights into the latest trends and requirements in the industry, making you a more attractive candidate.
✨Tip Number 3
Consider reaching out directly to hiring managers or recruiters at companies you're interested in. A well-crafted message expressing your interest and qualifications can set you apart from other candidates.
✨Tip Number 4
Stay updated on the latest regulations and guidelines in the pharmaceutical industry. Being knowledgeable about current standards will not only enhance your skills but also demonstrate your commitment to the role during interviews.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in medical writing, particularly in the pharmaceutical sector. Emphasise your ability to produce clinical and regulatory documents, as well as any specific therapeutic areas you have worked in.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for medical writing and your understanding of the role. Mention your experience with regulatory submissions and your ability to analyse and interpret data effectively.
Highlight Key Skills: In your application, clearly outline your strong writing skills and your proficiency in creating various clinical documents. Provide examples of how you've successfully led document preparation and ensured submission-readiness in previous roles.
Proofread Your Application: Before submitting, thoroughly proofread your application materials. Ensure there are no grammatical errors or typos, as attention to detail is crucial in medical writing. A polished application reflects your professionalism and commitment.
How to prepare for a job interview at Key Life Sciences
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Be prepared to discuss specific examples of documents you've authored, such as clinical study reports or protocols. Highlight how you transformed complex data into clear, concise messages.
✨Demonstrate Regulatory Knowledge
Since the role requires strong regulatory knowledge, brush up on the latest guidelines and regulations relevant to clinical documentation. Be ready to discuss how you've applied this knowledge in past roles, especially in relation to submission-ready documents.
✨Prepare for Technical Questions
Expect technical questions about the types of documents you'll be working on. Familiarise yourself with the specifics of clinical study documents and lean writing strategies. This will show that you understand the nuances of the role and can hit the ground running.
✨Emphasise Collaboration Skills
The position involves working closely with Principal Medical Writers and other team members. Be prepared to share examples of how you've successfully collaborated in the past, particularly in managing timelines and facilitating document reviews.
