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For Companies At a Glance
- Tasks: Create and manage clinical and regulatory documents for a top-tier pharma company.
- Company: Join a leading pharmaceutical firm dedicated to impactful healthcare solutions.
- Benefits: Enjoy stable employment while being fully integrated with our client, plus opportunities for professional growth.
- Why this job: Make a difference in healthcare by delivering essential documents that support patient safety and drug approval.
- 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 48000 - 72000 £ per year.
Job Description
Senior Medical Writer – biotech pharma\\n\\nWe are looking for experienced pharmaceutical Sr. Medical Writer.\\nAs a Senior Medical Writer you will be supporting a Top-tier pharma company. You have the chance to help our customer to deliver regulatory and submission documents.
While being stably employed with us, you will be fully embedded with our client.\\n\\nMain responsabilities:\\n\\n * 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.\\n\\n * Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.\\n\\n * Acts as the primary contact for the study team in relation to the preparation and timelines (incl. planning) of assigned documents.\\n\\n * 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.\\n\\nRequirements:\\n\\n * Minimum requirement of a bachelor’s degree; Master's degree preferred\\n\\n * 3-5 years Medical Writing experience in relevant pharmaceutical companies combined with scientific and regulatory knowledge (a must).\\n\\n * Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured messages.\\n\\n * 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.\\n\\nPlease note that prior experience as regulatory writer (min 3 years) in a pharmaceutical setting is mandatory and only profiles who match the criteria will to 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
Make sure to highlight your experience in writing clinical and regulatory documents. Since the role requires proficiency in creating various types of documents, emphasize any specific projects you've worked on that align with this.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those who have experience as Medical Writers. Engaging with them can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Familiarize yourself with the latest trends and regulations in medical writing. Being knowledgeable about current guidelines will not only help you in interviews but also demonstrate your commitment to the field.
✨Tip Number 4
Prepare for potential technical questions during the interview by reviewing common challenges faced in medical writing. This will show your analytical skills and ability to critically interpret data, which are crucial for the position.
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Understand the Role: Make sure you fully understand the responsibilities of a Senior Medical Writer. Familiarize yourself with the types of documents you'll be expected to produce and the regulatory requirements involved.
Highlight Relevant Experience: In your application, emphasize your 3-5 years of Medical Writing experience in pharmaceutical companies. Be specific about the types of clinical and regulatory documents you've worked on and any relevant therapeutic areas.
Showcase Your Writing Skills: Provide examples of your writing that demonstrate your ability to convert complex scientific data into clear and structured messages. If possible, include links or attachments of previous work that align with the job requirements.
Tailor Your Application: Customize your CV and cover letter to reflect the specific skills and experiences mentioned in the job description. Use keywords from the job listing to ensure your application stands out to recruiters.
How to prepare for a job interview at Key Life Sciences
✨Showcase Your Writing Skills
Prepare to discuss your writing process and provide examples of clinical and regulatory documents you've produced. Highlight how you convert complex scientific data into clear, structured messages.
✨Demonstrate Regulatory Knowledge
Be ready to talk about your experience with regulatory submissions and the types of documents you've worked on. Familiarize yourself with the specific requirements of the pharmaceutical industry to show your expertise.
✨Discuss Collaboration Experience
Since you'll be working closely with Principal Medical Writers and study teams, share examples of how you've successfully collaborated in the past. Emphasize your ability to coordinate and facilitate document reviews.
✨Prepare for Technical Questions
Expect questions that assess your analytical skills and understanding of clinical trial phases. Be prepared to discuss how you approach data interpretation and document preparation in a regulatory context.
