Senior Staff Clinical Scientist
Stryker is seeking Senior Staff Clinical Scientist to join our Neurovascular Division to be based in Fremont, CA or remotely anywhere within the United States.
What you will do
As the Senior Staff Clinical Scientist, you will represent the Clinical Science function on project and study teams to develop clinical evidence strategies as well as deliverables related to studies. You will project manage clinical deliverables within clinical science and medical writing from other team members and/or vendors.
Produce deliverables as needed: clinical activity or study plans and reports, and clinical evaluation / post-market clinical follow up plans, clinical strategy documentation, literature summaries, clinical regulatory submissions and responses, real world evidence protocols and reports
Collaborate with other staff to resolve complex or unclear situations and to mitigate gaps or risk in evidence needs
Provide critical elements and data for the clinical evidence portfolio rollups and roadmaps
Provide clinical science subject matter expertise and consultation to Biostatistics, Data Management, Regulatory Affairs, Clinical Safety and other internal and external stakeholders.
Assist in the development of junior team members as well as peers in clinical science and medical writing through deep subject matter knowledge
Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Contribute to Pre-Submissions, Design and Value dossiers for matrix submissions.
As needed, participate in opportunities to internal procedures and templates
What you need
Required
Bachelor’s Degree required; emphasis in health/science-related field preferred
6+ years of combined experience in clinical research, medical writing, clinical science
Previous medical writing experience in a healthcare product or medical device industry
Must be able to think analytically, have the ability to process scientific and medical data, with the ability to multi-task and problem solve
Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments
Excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/MDR/GCP) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology
Preferred
Advanced degree (MSc, MPH, PhD) in epidemiology, health services research, health outcomes research, biostatistics, data science, or related field
Experience in research study design, including producing synopses, protocols, and study reports
Experience in publication writing and submission
Experience in IDE / Class III products/ clinical trials
Previous knowledge of the Vascular space
Knowledgeable in AMWA code of ethics and appropriate guidelines
$100,500.00 - $215,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Travel Percentage: 10%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.
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