Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stikers.com'
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 Staff 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. 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
- 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.
- initiatives, regulation and industry trends for sales, management and leadership teams.
- 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 Staff Medical Writer, you will represent the Clinical Science function on the clinical project team. You will maintain responsibility for managing clinical science 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 including Clinical Evaluation Plans and reports, PMCF Plans and reports, summary of effectiveness and safety from raw data or summary tables.
- Perform formal literature searches, and succinctly summarize scientific content for assigned projects. Contribute to Pre-Submissions, Design and Value dossiers for matrix submissions.
- 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.
- Strong scientific and medical writing skills required including a minimum of 3 years of medical writing experience required.
- Experience in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses, literature summaries required.
- Previous medical device experience 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.
- 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.