Job Details
Posted 16 July, 2026
Job Id: 629315
MDR – Sr Prin Clinical Research Spec (CER Writer)
Job Description
Can you please provide a summary of the project/initiative which describes what’s being done? Our CER-OMA team supports our clinical-regulatory filings for all pre-market and post-market technologies across all geographies and support our global medical affairs operations with real-time scientific use-case assessments and dissemination.
What does the team make-up look like – how many members and what is the break-down of the team’s skill sets (ex: 1 PM, 4 Developers, etc.)? I have 4 team members with mixed tenured scientific backgrounds. Across the team we have strong medical writing, biostats, medical research, and decades of industry experience.
What are the top 5 responsibilities for this position? (Please be detailed as to what the candidate is expected to do or complete on a daily basis)
- Lead the authoring and critical review scientific and Clinical Evaluation documents.
- Analyze complex clinical data into clear, accurate, and defensible written summaries
- Ensure documents are scientifically sound and consistent.
- Function as a recognized independent SME who can influence decisions
- Provide strategic clinical input to internal teams and leadership.
- Represent Clinical in cross-functional planning and help the organization understand the clinical implications of decisions.
What skills/attributes are a must have (Please be detailed as to number of years of experience)? Exceptional medical writing experience
- Deep clinical research and clinical evidence development experience
- Expert-level ability to write, edit, and finalize document
- Ability to connect scientific evidence to regulatory, commercial, and clinical needs
- Exceptional medical writing and scientific communication
What skills/attributes are nice to have? foundational cardiac knowledge and experience with electrophysiology procedures/technology
What does the interview process look like?
- How many rounds? 2-3
- Video vs. phone? Mix as needed
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
