Principal Clinical Evaluation Medical Writer
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Job Location:
Mounds View, MN - USA
Yearly Salary:
$ 147000 - 196800
Posted on:
23 hours ago
Vacancies:
1 Vacancy
Job Summary
Position Description:
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 Investigators 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) MDCGMDCGMDCGMDCGand 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.
Basic Qualifications:
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 Medical Device Coordination Group (MDCG) MDCGMDCGMDCGMDCGand 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.
Salary: $147000 to $196800 per year
The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).
The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).
Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.
Further details are available at the link below:
Required Experience:
Staff IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
