Senior Clinical Evaluation Medical Writer - CRDN

Medtronic • Mounds View, MN

361d • $103,200 - $154,800 • Remote

About The Position

In this exciting role as a Senior Medical Writer for the Coronary & Renal Denervation Operating Unit, you will have primary responsibility for developing Clinical Evaluation Reports, Post Market Surveillance/Update Reports, Post Market Clinical Follow-up Plans/Reports, Summary of Safety and Clinical Performance documents and collaborating on a number of other clinical and regulatory documents. This individual is also responsible for administration of the applicable databases. This individual will partner closely with clinical research managers, regulatory affairs managers, quality specialists, and biostatisticians to develop a schedule and timely execute tasks. The Coronary & Renal Denervation therapies are a vital component of the Medtronic interventional cardiology portfolio. In addition to our core products that treat blocked coronary arteries, we are seeking to solve unmet needs in the rapidly growing field of complex percutaneous coronary intervention (PCI). We also are leading the way with the transformational renal denervation therapy, which has the potential to be a powerful tool in battling the global hypertension epidemic.

Requirements

• Bachelor's degree
• Minimum of 4 years clinical/medical/scientific writing experience OR Advanced degree and a minimum of 2 years clinical/medical/scientific writing experience.

Nice To Haves

• Advanced degree (PhD, PharmD, MD or MS)
• Medical writing and/or clinical research experience within a medical device industry
• Proficiency with European Union Medical Device Regulations (EU MDR)
• Experience conducting literature searches and literature reviews
• Experience with coronary or peripheral products
• Experience in preparation of Clinical evaluation reports and post market surveillance reporting.
• Proficiency with current EU MDR regulatory agency guidance and regulations
• Experience with medical writing tools and database (e.g., Endnote, Cite-While-You-Write) and technical publication tools (i.e. Adobe Acrobat, Publisher, MS Project)
• Excellent scientific writing skills
• Strong data extraction and analysis skills
• Proactive with a sense of urgency in managing job responsibilities
• Self-motivated and able to work independently.
• Analytical thinking and inquisitive mindset
• Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint)

Responsibilities

• Primarily responsible for writing and maintaining Clinical Evaluation Reports and Post Market Surveillance Reports for all the Cardiovascular portfolio of products.
• Collaborate (writing, reviewing, editing and approval) with clinical, R&D, quality assurance, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing brochures, post-market surveillance reports, risk management documents and other documents that require the evaluation of clinical data and/or clinical literature.
• Collaborate with regulatory teams on all phases of regulatory submissions and approvals, including clinical document preparation and review, regulatory document review and the formulation of responses to regulatory agencies.
• Collaborate with clinical and statistical teams on in-depth data description, presentation and analysis; provide clinical literature context and manage data analysis deliverables.
• Develop and maintain in-depth therapeutic and product operation knowledge; apply this knowledge to the development of well written clinical evidence documents and in support of cross-functional teams.
• Develop and maintain in-depth knowledge of clinical research best practices, including the planning, execution, and documentation of clinical trials, related Standard Operation Procedures (SOPs), International Standards Organization (ISO) guidelines and regulatory agencies' guidelines on clinical research conduct.
• Create and manage project schedules for each clinical evidence document.
• Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.
• Administration of the applicable databases for the activities related to the evaluation of clinical data, Clinical Evaluation reports and Post Market surveillance reporting.
• Consistently apply applicable global regulations and guidelines, as well as Medtronic policies and procedures.
• Maintain and update spreadsheets tracking the status for CER projects.
• Collect and maintain all documents necessary to ensure compliance with SOP.
• Compiles, analyzes, and summarizes additional data from other sources as needed.
• May prepare responses regarding company products, drugs, or diseases and refers in-depth technical inquiries to medical personnel.

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)

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees