MDR - Sr Principal Clinical Research Specialist / Clinical Scientist
Job Description
Technical Skills
Must Have
- CER and PER Medical Writer
- Preparation of CER and TF
Nice To Have
- A clinical medical writer
- Ad-hoc CER Medical Writer 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 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.
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 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 are the work hours? (ex. 9am-5pm, day/night shifts, rotating shifts, etc) normal day shift
What does the interview process look like?
- How many rounds? 2-3
- Video vs. phone? Mix as needed
