Senior Manager, Clinical Science-Medical Writing

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Manager, Clinical Science-Medical Writing to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere in United States.Stryker’s Neurovascular division is focused on advancing the practice of less invasive stroke therapies through its Complete Stroke Care solutions. The business is dedicated to providing innovative stroke products and services for ischemic and hemorrhagic stroke and committed to providing clinical education and support to help physicians deliver better patient outcomes. Products include: stent retrievers, detachable coils, stents, balloons, guidewires and microcatheters. In February 2019, Stryker Corporation (NYSE:SYK) announced that for the ninth consecutive year has been named as one of the FORTUNE 100 Best Companies to Work For ranking 11 out of 100. If you join our organization; will be working to “Make Stroke History”. Stroke is devastating; 1 of 20 deaths is from a stroke, according to the CDC. Watch this video to see how Stryker is making a difference: https://www.youtube.com/watch?v=JANFZrpt1Hg .Who we wantAccuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.

Subject matter experts . Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.

What you will doAs the Senior Manager, Clinical Science-Medical Writing you will deliver to department vision and goals, you will serve as the department leader for Global Clinical Science. You will manage a team of 4-10 individuals across geographies and maintain responsibility for managing clinical science deliverables across business franchises (flow diversion, Stents/Coils and AIS). You will work with confidential company data and interface with cross-functional internal and external stakeholders. You will contribute towards regulatory reports, podium and publication planning and execution deliverables.You will represent Stryker Neurovascular as the clinical science subject matter expert for the Neurovascular product portfolio developing and maintaining in-depth therapeutic and product knowledge.Recruit, onboard, train and manage talent for building organizational capabilities.

Create efficient business processes, procedures, templates and enabling tools to contribute to building the Clinical Sciences - Center of Excellence (CoE).

Manage Clinical Science deliverables (clinical development and evidence based plans/protocols and reports, literature summaries, evidence briefs, publications and presentations) and metrics with efficient planning, scheduling and resource allocations.

Manage resource allocation, vendors, consultants, budget accruals and department key performance indicators.

May author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data.

May perform formal literature searches, and succinctly summarize scientific content for assigned projects.

Provide clinical science subject matter expertise and consultation to Clinical Research Associates, Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.

Collaborate with other department heads to resolve complex or unclear situations.

Responsible for staff training plans.

What you needA minimum of a Bachelor’s Degree is required or equivalent in health care field (RN, BSN, MBBS, DPharm) is required.

A MD, NP, PhD in Biological or Life Sciences, or Master’s in Public Health preferred.

A minimum of 10 years progressive clinical research experience required.

A minimum of 3 years of people and process management experience required.

Previous experience with medical writing (regulatory reports, literature summaries, abstracts and publications) required.

Extensive knowledge of clinical trial experience required.

Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.

Working knowledge of Global Medical Device Regulatory Requirements preferred.

FDA and EU-MDR experience preferred.

Demonstrated work experience to Recruit, Manage, Coach, Mentor and Develop talent for the organization required.

Experience in IDE / Class III products/ clinical trials preferred.

Vascular experience preferred.

Work From Home: RemoteTravel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com