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 Medical Writer 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: [ Link removed ] - Click here to apply to Senior Medical Writer.
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.
Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
What you will do
As the Senior Medical Writer, you will represent the Clinical Affairs function on clinical project team. You will maintain responsibility for managing Clinical Affairs deliverables. You will work with confidential company data and you will interface with cross-functional internal and external stakeholders.
- Author clinical trial protocols, interim and final clinical study reports, integrated safety/performance data summaries from raw data.
- 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 staff to resolve complex or unclear situations.
- Propose and participate in departmental continuous improvement initiatives.
- Assist in training staff.
What you need
- A minimum of a Bachelor’s Degree required; emphasis in health/science-related field preferred.
- A Master’s or Ph.D. or other higher degree in health-related field (RN, BSN, BPharm/MD/MPH) preferred.
- A minimum of 6 years of combined experience in clinical research, medical writing, clinical science required or 3 years of combined experience in clinical research, medical writing, clinical science with a Master’s Degree or 2 years of combined experience in clinical research, medical writing, clinical science with a PhD required.
- Strong scientific and medical writing skills required.
- Experience in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required.
- Experience in IDE / Class III products/ clinical trials preferred.
- Previous knowledge of the Vascular space preferred.
- 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.
- Knowledgeable in AMWA code of ethics and appropriate guidelines required.
- Adept at word and power point processing, document management and change control.
- Excellent working knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology preferred.
Work From Home: Occasional
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.
Clinical Study Reports
Good Clinical Practices (Gcp)