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 Affairs-Medical Writing to join our Neurovascular division to be located in 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:
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 Affairs-Medical Writing and team leader, you will ensure that the medical writing that we create is top notch. You will work directly with medical writers and external consultants. You will use product knowledge and quick thinking to respond to national and international regulatory agencies. You will also develop a Medical Writing team that becomes a Center of Excellence. Your role can be shortened to: managing medical writing excellence and advancing stroke science globally.
* Lead and develop a team of two medical writers and several medical writing consultants. * Oversee medical writing excellence of internal project teams and functions, external study investigators, and interaction with regulatory agencies. * Manage creation and updating of national and international clinical reports of medical devices throughout the product lifecycle. * Establish medical writing program strategy.
What you need
* A minimum of a Bachelor's Degree (BA or BS) in a technical or scientific discipline required. * A Master's Degree or MBA preferred. * A minimum of 8 years of medical writing experience required. * Extensive knowledge of 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 25%
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.