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For Companies At a Glance
- Tasks: Lead medical writing projects and ensure clear, accurate scientific communication.
- Company: Join Syneos Health, a global leader in biopharmaceutical solutions.
- Benefits: Enjoy career development, supportive management, and a diverse workplace culture.
- Why this job: Make a real impact on patient lives through innovative medical writing.
- Qualifications: 3-5 years in medical writing with strong regulatory knowledge.
- Other info: Remote role with opportunities for mentorship and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
Job Responsibilities
- Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately.
- Manage medical writing activities for individual studies, coordinating with other departments with minimal supervision.
- Lead the resolution of client comments.
- Complete a variety of documents including clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; abstracts, posters, and presentations for scientific meetings.
- Adhere to regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates, authorship requirements, and style guides, delivering projects on time and on budget.
- Coordinate quality and editorial reviews.
- Ensure source documentation is managed appropriately.
- Lead team document reviews and perform reviews as needed.
- Act as peer reviewer for the internal team to ensure scientific quality, clarity, consistency, and proper format.
- Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
- Provide feedback to define statistical output and document needs.
- Interact and build working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
- Perform online clinical literature searches and comply with copyright requirements.
- Identify and propose solutions to resolve issues, escalating as appropriate.
- Provide technical support, training, and consultation to department and other staff.
- Contribute to development of internal materials and presentations or process changes.
- Mentor and lead less experienced medical writers on complex projects.
- Develop deep expertise in key industry topics and regulatory requirements that affect medical writing.
- Work within budgeted hours, and communicate status and changes to leadership.
- Complete administrative tasks within specified timeframes.
- Perform other work-related duties as assigned.
- Minimal travel may be required (less than 25%).
Qualifications
- 3-5 years of relevant experience in science, technical, or medical writing.
- Experience working in the biopharmaceutical, device, or CRO industry.
- Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
- Experience writing relevant document types.
- Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.
At Syneos Health, we are dedicated to building a diverse, inclusive, and authentic workplace. If your past experience doesn’t align perfectly, we encourage you to apply anyway. Join our Talent Network to stay connected to career opportunities. Discover what our 29,000 employees already know: work here matters everywhere.
Senior Medical Writer employer: Syneos Health, Inc.
Contact Detail:
Syneos Health, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer
✨Tip Number 1
Network like a pro! Reach out to your connections in the biopharmaceutical field and let them know you're on the lookout for opportunities. A friendly chat can lead to insider info about job openings that aren't even advertised yet.
✨Tip Number 2
Prepare for interviews by researching Syneos Health and its projects. Knowing the company’s mission and recent achievements will help you stand out. Plus, it shows you’re genuinely interested in being part of the team!
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the Senior Medical Writer role. Highlight your skills in managing medical writing activities and your understanding of regulatory standards to impress the interviewers.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, you’ll find all the latest job openings there, so keep checking back for new opportunities!
We think you need these skills to ace Senior Medical Writer
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Senior Medical Writer role. Highlight your relevant experience in medical writing and any specific projects that align with what we do at Syneos Health.
Showcase Your Skills: Don’t just list your qualifications; demonstrate how your skills meet the job requirements. Use examples from your past work to show your understanding of FDA and ICH regulations, as well as your ability to produce high-quality documents.
Be Clear and Concise: As a medical writer, clarity is key! Ensure your application is well-structured and free of jargon. We want to see your ability to communicate complex information clearly right from the start.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands and shows your enthusiasm for joining our team at Syneos Health!
How to prepare for a job interview at Syneos Health, Inc.
✨Know Your Stuff
Make sure you brush up on your knowledge of FDA and ICH regulations, as well as the specific document types you'll be working with. Being able to discuss these confidently will show that you're not just familiar with the basics but have a deep understanding of what's required in medical writing.
✨Showcase Your Experience
Prepare examples from your past work that highlight your experience in managing medical writing activities and resolving client comments. Use the STAR method (Situation, Task, Action, Result) to structure your responses, making it easy for the interviewer to see your impact.
✨Ask Insightful Questions
Come prepared with questions that demonstrate your interest in the role and the company. Ask about their Total Self culture or how they support career development. This shows that you’re not just looking for any job, but are genuinely interested in being part of their team.
✨Be Ready to Collaborate
Since this role involves working closely with various departments, be ready to discuss how you’ve successfully collaborated in the past. Highlight your ability to build relationships and communicate effectively with peers and clients, as this is crucial for success in a remote environment.
