Senior Clinical Research Specialist

Medtronic • Irvine, CA

4d • Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life In this exciting role you will have primary responsibility for leading and developing clinical, scientific, and regulatory documents while working in a cross-functional team in accordance with the highest quality standards. This is a dynamic opportunity where you will also be involved in global clinical development activities and clinical strategy. Prefer candidates who can work in Irvine, CA At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

Requirements

• Bachelor’s degree in a technical discipline
• Minimum of 4 years of relevant experience or advanced degree with a minimum of 2 years of relevant experience

Nice To Haves

• MD or PhD degree in biomedical sciences or other relevant technical disciplines is highly preferred
• Experience with clinical trials, clinical/medical and/or scientific writing or publication at Medtronic Neurovascular medical device or stroke therapeutic area experience

Responsibilities

• Develop clinical strategy and author clinical documents including but not limited to clinical study protocols, clinical study reports, clinical evaluation plans/reports, annual progress reports, clinical risk benefit analyses, and clinical marketing materials.
• Collaborate with cross-functional teams, such as marketing, sales, clinical, R&D, HE&R, Quality, Compliance and Regulatory, and may represent clinical on core teams for new product development and/or product expansions.
• Develop and maintain strong scientific knowledge of the therapeutic area, disease state, and current competitive landscape, with the ability to effectively write key clinical deliverables/sections of regulatory submissions, including regulatory responses.
• Develop a deep understanding of clinical data: how to interpret and effectively communicate/present the data, summarizing complex results, and presenting them in a clear, concise, and scientifically accurate manner to a wide-range of audiences..
• Conduct thorough scientific literature reviews and clinical evidence mapping, manage the literature database and prepare literature reviews for external and internal stakeholders, or for regulatory submissions.
• Develop and lead the execution of publication strategies in collaboration with internal and external stakeholders (e.g., physician investigators, KOLs).
• Participate in the periodic reviews of recent scientific publications/conference presentations relevant to the business, draft article summaries for distribution to key stakeholders.
• Plan, direct, and drive multiple business critical projects in parallel to completion on time with independence under limited supervision.
• For all documents: author drafts, coordinate and manage the review process, lead discussions on document revision, revise document per comments from external and internal reviewers, and ensure timely approvals from all reviewers.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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: Mid Level
• Number of Employees: 5,001-10,000 employees