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Senior Manager, Medical Safety in Fremont, CA at Stryker Corporation

Date Posted: 5/16/2019

Job Snapshot

Job Description

Who we are

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. We are currently seeking a Senior Manager, Medical Safety to join our Neurovascular division to be located in either Fremont, CA or remotely anywhere within the US.

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 2016 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 want

  • A lover of their team. Sees their team as unique individuals each deserving respect, dignity, and growth.
  • A vision-maker. Repeatedly tells their team what they’re working for and why it’s important.
  • A compass. Has high moral and ethical standards always, not just when someone is looking.
  • A connector. Communicates often and openly and creates a feeling of succeeding and failing together.
  • A victor. Dependably executes the plan after generating it; someone who refuses to throw in the towel, pass the buck, or throw someone else under the bus when something doesn’t get done.

What you will do

As the Senior Manager, Medical Safety and team leader you will make sure our devices do not cause adverse patient effects. You will work directly with study investigators and regulatory agencies. You will use product knowledge and quick thinking to solve problems and let doctors and nurses know about proper product use. You will also develop a Safety team as unique individuals. Your role can be shortened to: safeguarding patients and advancing stroke science globally.

  • Lead and develop a team of four medical research Safety associates
  • Give medical guidance to internal project teams and functions, external study investigators, and regulatory agencies
  • Approve adverse event narratives for medical accuracy
  • Oversee Clinical Evaluation Reports and strategies
  • Lead the team which performs medical monitoring to ensure patient safety and adequate coding and reporting of adverse events
  • Collaborate with Quality Assurance in medical device reporting, health risk assessments, and product performance criteria

What you need

  • A minimum of a Bachelor’s Degree in a Biological or Life Sciences or equivalent focus is required or a minimum of being a RN along with relevant industry experience is required.
  • A MD, NP, PhD in Biological or Life Sciences, or Master’s in Public Health preferred.
  • A minimum of 10 years of progressively increasing responsibility in a clinical or health-related field required.
  • A minimum of 3 years of medical safety and clinical trial experience required.
  • Medical device industry experience strongly preferred.
  • Previous experience managing a team of direct reports 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.

Work From Home: Yes

Travel Percentage: Up to 50%

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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