Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Create impactful regulatory documents for global submissions in oncology.
- Company: Join a leading biotech firm dedicated to innovative cancer treatments.
- Benefits: Enjoy remote work flexibility, competitive salary, and professional growth opportunities.
- Why this job: Make a difference in oncology by shaping critical clinical documents.
- Qualifications: Experience in medical writing and understanding of regulatory standards required.
- Other info: Collaborate with global teams and contribute to groundbreaking research.
The predicted salary is between 36000 - 60000 £ per year.
Responsibilities include developing regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate. eCTD submission experience preferred.
The Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (e.g., Investigators' Brochures, Clinical Study Reports, and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements.
Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards.
Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based in City of Westminster employer: Syneos Health
Contact Detail:
Syneos Health Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based in City of Westminster
✨Tip Number 1
Network like a pro! Reach out to professionals in the oncology field on LinkedIn or at industry events. A friendly chat can open doors and give you insights that job descriptions just can't.
✨Tip Number 2
Prepare for interviews by practising your responses to common questions. Think about how your experience aligns with developing regulatory documents and managing projects. We want you to shine!
✨Tip Number 3
Showcase your expertise! Bring samples of your previous work to interviews, especially if they relate to clinical study reports or regulatory submissions. It’s a great way to demonstrate your skills.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based in City of Westminster
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Principal Medical Writer role. Highlight your experience with regulatory documents and any relevant projects you've worked on. We want to see how your skills align with our needs!
Showcase Your Experience: When detailing your past roles, focus on your experience in developing clinical documents and managing timelines. Mention any eCTD submission experience you have, as it’s a plus for us. We love seeing concrete examples of your work!
Be Clear and Concise: In your written application, clarity is key! Use straightforward language and avoid jargon unless necessary. We appreciate well-organised documents that get straight to the point, just like we do in our writing.
Apply Through Our Website: Don’t forget to submit your application through our website! It’s the best way for us to receive your details and ensures you’re considered for the role. We can’t wait to see what you bring to the table!
How to prepare for a job interview at Syneos Health
✨Know Your Regulatory Stuff
Make sure you brush up on ICH guidelines and global regulatory standards. Being able to discuss these in detail will show that you’re not just familiar with the basics but can navigate the complexities of regulatory submissions.
✨Showcase Your Project Management Skills
Be ready to talk about how you've managed timelines and communicated with cross-functional teams in past projects. Use specific examples to illustrate your ability to keep everyone on track and ensure timely delivery of documents.
✨Prepare for Cross-Functional Collaboration
Think about times when you’ve participated in cross-functional meetings. Be prepared to discuss how you contributed to discussions about medical writing deliverables and how you handled any challenges that arose during those collaborations.
✨Highlight Your Writing Experience
Bring examples of your previous work, especially any clinical documents you’ve developed. Discuss your approach to ensuring scientific rigor and logical organisation in your writing, as well as how you’ve interpreted data accurately in your submissions.
