At a Glance
- Tasks: Transform scientific data into impactful medical documents in a fast-paced biotech environment.
- Company: Join Proclinical, a leader in rare disease and biotechnology innovation.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team culture with a focus on career development.
- Why this job: Make a real difference in healthcare by producing essential clinical documents.
- Qualifications: Bachelor's in Life Sciences or English/Communications with relevant writing experience.
The predicted salary is between 60000 - 80000 £ per year.
Turn science into submission‑ready success‑led medical writing in a fast‑paced biotech setting. Proclinical is seeking a Senior Manager, Medical Writing to join a dynamic team in the rare disease and biotechnology space. In this role, you will collaborate with cross‑functional project teams to develop high‑quality clinical documents while ensuring compliance with applicable regulations and standards. This hybrid position requires two days per week in the office.
Responsibilities
- Produce high-quality, timely writing deliverables, including clinical protocols, investigator brochures, clinical study reports, and related documents.
- Independently plan, write, edit, and format key clinical documents.
- Manage and facilitate the review and finalization process for documents created internally or by external consultants, contractors, and vendors.
- Represent Medical Writing on early‑phase or specific late‑phase project teams, collaborating with leadership to ensure proper planning and resourcing for deliverables.
- Collaborate effectively with internal teams such as Biometrics, Clinical Operations, Regulatory Affairs, and others, as well as external stakeholders.
- Serve as a subject matter expert for clinical document production.
- Contribute to the development and maintenance of SOPs and templates.
Key Skills and Requirements
- Bachelor's degree in Life Sciences with relevant writing expertise or in English/Communications with relevant science expertise; advanced degrees or certifications are a plus.
- Proven experience as a medical writer, ideally with exposure to regulatory submissions (e.g., CTA, IND, NDA, BLA) and knowledge of eCTD formatting.
- Strong understanding of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
- Demonstrated ability to manage multiple projects in a fast‑paced, deadline‑driven environment.
- Exceptional attention to detail and ability to deliver high‑quality work on time.
- Experience overseeing contract writers is advantageous.
- Proficiency in Microsoft Word, Excel, and PowerPoint.
- Willingness to travel approximately 10%.
Contact: Ash Aravindhan at a.aravindhan@proclinical.com.
Senior Manager, Medical Writing in Maidenhead employer: Proclinical Group
Proclinical is an exceptional employer that fosters a collaborative and innovative work culture, particularly in the fast-paced biotech sector. With a strong focus on employee growth, we offer opportunities for professional development and the chance to work on impactful projects in rare diseases. Our hybrid work model allows for flexibility while maintaining a supportive team environment, making it an ideal place for those seeking meaningful and rewarding careers.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Medical Writing in Maidenhead
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We think you need these skills to ace Senior Manager, Medical Writing in Maidenhead
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show Proclinical Group that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at Proclinical Group.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that Proclinical Group does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at Proclinical Group
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at Proclinical Group. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into Proclinical Group's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at Proclinical Group. This shows your passion for the industry!
