Principal Medical Writer (Remote)

We are currently seeking a Principal Medical Writer to join our Sports Medicine Business Unit, part of the Stryker Endoscopy Division, to be based remotely anywhere within the United States.  

Our Sports Medicine team delivers a wide range of innovative sports medicine implants, instrumentation, resection and biologic solutions, focusing on minimally invasive and open approaches to the shoulder, knee, hip and small joints. 

Learn more about the exciting ways our team is advancing sports medicine on our LinkedIn page: https://www.linkedin.com/showcase/stryker-sports-medicine/. 

Who we want

• 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. 

 • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

• 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. 

What you will do

As a Principal Medical Writer, you will support generation of high-quality clinical documents such as manuscripts, clinical study reports, clinical evaluation documents, Post Market Clinical Follow-up documents and Summary of Safety and Clinical Performance on cross-functional project teams for NPD and sustaining and for both US and OUS markets. This position requires minimal supervision.

• Lead manuscript writing

• Lead clinical study reports, data summaries from raw data and document strategies in collaboration with cross-functional teams.

• Drive Clinical Evaluation Strategy for EU and Australia market access.

• Lead development and completion of Clinical Evaluation Reports (CERs), post market clinical follow-up (PMCF) and summary of safety and clinical performance (SSCP) documents for new medical devices to support product registrations internationally, maintain periodic updates, perform gap analysis, and revise existing CERs.

• Drive resolution to notified body feedback on EU clinical documents for continued EU market access of the products.

• Collaborate cross-functionally to provide input to PMO and design teams on Clinical documentation, related strategies, and timelines.

• Liaise with divisional and corporate partners to provide best-in-class global solutions and input into processes.

• Performs systematic literature reviews for medical device groups or sub-groups. Interprets literature information and synthesizes the information in clinical regulatory documents.

• Monitor changes in regulatory requirements. Responsible for the development, maintenance, and improvement of procedures and templates and style guides.

• Oversee process improvement for the better efficiency within the department and standardizing document creation process flow.

• Drives creation and maintenance of the Stryker Endoscopy medical writing tools.

• Represent expertise during internal and external audits of clinical evidence documents.

• Mentors and may direct work of Medical Writer, Senior Medical Writer or Staff Medical Writer.

What you need

• A Bachelor of Science Degree required, preferably in a health/science-related field.

• Doctorate degree in a health/science-related field preferred.

• Minimum 5+ years of medical writing experience in a Healthcare Product or Medical Device industry required.

• Minimum 9+ years of combined experience in healthcare products or medical devices.

• Expert knowledge and experience with MEDDEV 2.7/1 Rev. 4, EU Medical Device Regulation 2017/745 (MDR) and MDCG compliant clinical evaluations and clinical study documents required.

• Experience writing manuscripts and clinical study reports preferred.

• Excellent 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.

• Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.

• Strong knowledge in clinical operations, risk management, regulatory submissions and US, EU and other international guidelines preferred.

• Expert working knowledge of regulatory guidelines (FDA/CFR; EN540/ Med DEV/GCP/EU MDR/MDCG) and quality standards (ISO 14155/14971) and medical/scientific/disease state terminology.

• Ability to apply ISO, FDA, EU MDR, MDCG and related guidelines toward writing strategy and documentation required.

• Motivated, self-starter with the ability to work with minimal supervision, make independent decisions, technical aptitude, and attentiveness to detail.

• Excellent planning and organizational skills, with the ability to adapt and adjust to changing priorities.

• Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.

• Excellent communication, project management and influencing skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

• Excellent interpersonal skills, written, oral communication and negotiations skills.

• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

• Builds strong relationships by fostering open communication, respect, and trust.

• Act with a customer service/stakeholder-focused approach.

• Leverages excellent interpersonal keys to achieve desired outcomes.

• Act as the voice of Clinical Evidence in cross-functional teams, ensuring appropriate outcomes.

$109,500 - $232,900 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Our benefits:

• 12 paid holidays annually

• Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

• Financial benefits include Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits
About Stryker
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 Medical and Surgical, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com.
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Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.