• Senior Staff Clinical Scientist

    Stryker (Fremont, CA)


    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.

     

    This role will be posted for a minimum of 3 days.

     

    Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

     

    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.