Stryker Staff Medical Writer (Remote) in Jefferson City, Missouri
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 Staff Medical Writer to join our Endoscopy Division to be based in San Jose, CA or remotely anywhere within the United States.
Who we want
Self-directed initiators . People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.
What you will do
As a Staff Medical Writer, you will work closely with cross-functional teams (Regulatory, Clinical, Quality, Marketing) ensuring successful preparation of high-quality submission-ready clinical documents such as clinical evaluation documents, Post Market Clinical Follow-up documents, Summary of Safety and Clinical Performance and Clinical Study documents.
Compile clinical evidence from multiple sources such as current and past clinical trials, post market clinical follow up data and literature review updates, ad-hoc analysis, meta analyses, or other sources of safety and performance data (e.g. IIS clinical data, as available) and synthesizes the information in support of EU- MDR submissions, required CERs, and annual updates.
Responsible for the development and completion of Clinical Evaluation Reports (CERs) for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.
Collaborate cross-functionally to provide input for design teams for Clinical EU MDR documentation.
Work in a cross-functional team to author clinical study protocols and reports, data summaries from raw data and document strategies.
Prepare literature searches for drafting document content. Interprets literature information and synthesizes the information in clinical regulatory documents.
For all documents, coordinates and manages the review process, and leads discussions on document revision.
Challenge conclusions when necessary. Independently resolves document content issues and questions from external and internal reviewers and ensures timely approvals from all reviewers.
Assist in the development of internal procedures, templates and style guides.
Serve as a subject matter expert within department.
Recognize potential scheduling and resource conflicts for projects and provides recommendations to resolve.
May direct work of Medical Writer or Senior Medical Writer.
Assist in the creation and maintenance of the Stryker Endoscopy library for all relevant literature.
What you need
A Bachelor’s Degree required; preferably in a Scientific Discipline.
A Master of Science Degree in a Scientific Discipline preferred.
A minimum of 5 years of experience in healthcare products or medical devices required.
Previous medical writing experience in a healthcare product or medical device industry required.
Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations preferred.
Strong scientific and medical writing skills required.
Must be able to think analytically, have the ability to interpret data from scientific literature and clinical studies and synthesize the results and in a clear, concise, and scientifically accurate manner in the clinical document.
Ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.
Ability to apply ISO, FDA and related guidelines toward writing strategy and documentation preferred.
Work From Home: Remote
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.
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. More information is available at www.stryker.com