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Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations. -
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. -
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. - Conduct literature searches for drugs, medical devices, and cosmetics. Interpret and synthesize the information in clinical regulatory documents, in compliance with global requirements, including pharmacovigilance.
- Work in a cross-functional team and write clinical study protocols and reports, data summaries from raw data, and develop document strategies.
- 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. investigator-initiated study clinical data) and synthesize the information in support of European Medical Device Regulation (EU MDR).
- Develop and complete Clinical Evaluation Reports (CERs) for new and legacy 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 clinical EU MDR requirements.
- Translate complex scientific and technical information into accessible content for various audiences, including regulatory bodies.
- For all documents, coordinate and manage the review process, and lead discussions on document revision.
- Challenge conclusions when necessary. Independently resolve document content issues and questions from external and internal reviewers and ensure timely approvals from all reviewers.
- Assist in the development of internal procedures, templates, and style guides.
- Serve as a subject matter expert within the department.
- Assist in the maintenance of the library for all relevant literature.
- A Bachelor's Degree required; preferably in a Scientific Discipline.
- 4 years of Industry experience in pharma or medical devices is required
- 2 years of experience in Scientific or Medical Writing, relevant academic or clinical research experience (Masters or PhD) is preferred.
- Antiseptic/antibiotic experience required, including experience with topical formulations preferred.
- Understanding and experience in the use of scientific journals, publication guidelines, databases, search strategies, literature management software required
- Excellent scientific and medical writing skills required.
- Must be able to think analytically, can 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 apply ISO, FDA and related guidelines toward writing strategy and documentation required.
- Must be able to work and make independent decisions and be able to take the initiative to lead projects and assignments.
- Demonstrated ability to work effectively with cross-functional internal (Regulatory, Marketing, Research & Development) and external stakeholders (Physicians, CROs, Medical Staff, etc.) across multiple businesses.
- 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 preferred
- Knowledge in clinical operations, risk management, regulatory submissions and US and international guidelines preferred.
- Technical aptitude and attentiveness to detail.
- Excellent 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.
- 12 paid holidays annually
- Health benefits include:
- 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.
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Staff Medical Writer, - Cary, United States - Stryker
Description
Why join Stryker?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
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 atWe are currently seeking a
Staff Medical Writer , to join our
Medical Division. This is an individual contributor fully Remote position, located in the United States. Preference will be given to candidates located in the Midwest or Eastern United States.
Who We Want
What you will do
As a Staff Medical Writer, you will work closely with cross-functional teams (Marketing, Research and Development, Regulatory, and Quality) to create literature reviews and reports to support global pharmacovigilance activities.
What you need
About Stryker
Our benefits:
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.
About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better.
The company offers innovative products and services in MedSurg, 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 (http:
)
Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page )
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.
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.
