Principal Clinical Evaluation Medical Writer
About The Position
Principal Clinical Evaluation Medical Writer for Medtronic, Inc located in Mounds View, MN. Responsible for authoring clinical and scientific documentation to support product and therapy approval and use worldwide. Responsible for authoring clinical study documentation, including Clinical study reports, Investigator’s brochure, Clinical study protocols, Informed consent forms, Case report forms, Common technical document (CTD) modules and Biowaiver applications. Author scientific abstracts, posters, manuscripts and consensus guidelines for publication in scientific journals and podium presentations for Key Opinion Leaders (KOL). Review and analyze clinical evidence from clinical studies and scientific literature. Create responses for regulatory deficiency letters, audit and submission queries. Develop and maintain clinical documentation for cardiac surgery device regulatory submissions, including Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Plan/Report (PMCFP/R), Summary of Safety and Clinical Performance (SSCP), and Periodic Safety Update Reports (PSURs). Responsible for EU Medical Device Regulation (EU MDR) submissions for devices related to surgical cardiac ablation and extracorporeal circulation. Navigate the complexities of various government and industry regulations for the EU MDR, including EU MDR 2017/745, EU MEDDEV Guidance 2.7/1 Rev. 4, Medical Device Coordination Group (MDCG) MDCG-2019-9, MDCG-2020-5, MDCG-2020-6, MDCG-2020-7 and MDCG-2020-8. Position works a hybrid model and will be onsite at Mounds View, MN 4 days per week. Relocation assistance not available for this position. #LI-DNI.
Requirements
- Masters’ Degree in Biomedical Sciences, Medicine, Pharmacology, or related technical disciplines with five (5) years of experience as a medical writer or related occupation.
- Must possess at least five (5) years’ experience with each of the following: Authoring clinical study documentation; Authoring scientific abstracts, posters, manuscripts and consensus guidelines for publication in scientific journals and podium presentations for KOL; Reviewing and analyzing clinical evidence from clinical studies and scientific literature; and Creating responses for regulatory deficiency letters, audit and submission queries.
- Must possess at least one (1) year of experience in each of the following: EU MDR submissions for devices related to surgical cardiac ablation and extracorporeal circulation; Creating clinical documentation for regulatory submissions, including CEPs, CERs, PMCFP/R, SSCP, and PSURs; EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG-2019-9, MDCG-2020-5, MDCG-2020-6, MDCG-2020-7, and MDCG-
Responsibilities
- Authoring clinical study documentation
- Authoring scientific abstracts, posters, manuscripts and consensus guidelines for publication in scientific journals and podium presentations for Key Opinion Leaders (KOL)
- Reviewing and analyzing clinical evidence from clinical studies and scientific literature
- Creating responses for regulatory deficiency letters, audit and submission queries
- EU MDR submissions for devices related to surgical cardiac ablation and extracorporeal circulation
- Creating clinical documentation for regulatory submissions, including CEPs, CERs, PMCFP/R, SSCP, and PSURs
- EU MDR 2017/745, MEDDEV 2.7/1 Rev. 4, MDCG-2019-9, MDCG-2020-5, MDCG-2020-6, MDCG-2020-7, and MDCG-
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
