- 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: 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.
-
Staff Medical Writer,
1 week ago
Stryker Corporation Cary, United StatesAs 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. In addition, you will Medical, Staff, Writer, Clini ...
-
Staff Medical Writer,
3 weeks ago
Stryker Cary, United StatesWhy 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 w ...
-
Medical Writer
2 weeks ago
Collabera North Chicago, United StatesThe Medical Editor, Global Scientific Publications, is responsible for reviewing, editing, and supporting publication activities and submissions (including manuscripts, abstracts, posters, and oral presentations) to medical journals and scientific congresses. This individual prov ...
-
Senior Medical Writer
2 weeks ago
MMS Naperville, United StatesJob Description · Job DescriptionMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-e ...
-
Service Advisor
1 week ago
Northwest Freightliner Palatine, United StatesA little drive will take you far. Join a company values your motivation to make a difference, while also respecting your personal time. Join Northwest Freightliner, a family-owned transportation company that's been helping their employees grow for over 40 years. · Northwest Freig ...
-
Executive Communications Writer
3 weeks ago
Uline Pleasant Prairie, United States**Executive Communications Writer** · **Corporate Headquarters** · **12575 Uline Drive, Pleasant Prairie, WI 53158** · Are you a talented and detailed writer? Can you convey complex narratives in a way that is simple and easy to understand? Then you belong at Uline As an Executiv ...
-
Content Editor
3 weeks ago
National Association of Boards of Pharmacy (NABP) Mount Prospect, United StatesThis position is exempt and offers a hybrid work model._ · **Responsibilities**: · **Program Support** · - Reviews and edits new and existing items as assigned to ensure content is clear, accurate, and consistent for all NABP examinations. · - Uses established style guidelines to ...
-
Content Editor
3 weeks ago
National Association of Boards of Pharmacy Mount Prospect, United States_This position is exempt and follows a hybrid work model. _ · As a member of the Content team, the **Content Editor** works with NABP staff and SMEs (e.g., Review Committee Members, Item Writers, etc.) to ensure content is clear, accurate and consistent for all NABP examinations. ...
-
Service Advisor
3 weeks ago
TYLER KIA Niles, United StatesAs a _Tyler Kia _Service Advisor_, you'll be at the forefront of the automotive industry, promoting the most innovative parts and accessories available on the market today, and working with the latest in diagnostic technology in a state-of-the-art environment. · Reporting to the ...
-
Content Writer
1 week ago
Midwest Goods Inc. Bensenville, United States**Position**: Content Writer · **Reports to**:Marketing Manager · **Location**:Onsite Bensenville, IL /Elk Grove Village, IL · **Compensation**: Starts at $58,000 · **$300 Sign-on Bonus After Completion of the 90-day Probationary Period** · **Summary/Objective** · Midwest Goods i ...
-
Field Service Power Generation Technician
2 weeks ago
Interstate Companies Inc Carol Stream, United StatesInterstate Companies, Inc. is a dynamic organization that provides rewarding careers for more than 1,500 employees in its corporate office and five operating units - Interstate Assembly Systems, Interstate Bearing Systems, Interstate Industrial Systems, Interstate Power Systems, ...
-
Estimator
3 weeks ago
Gerber Collision & Glass Melrose Park, United States**Company: Gerber Collision & Glass** · **WELCOME TO GERBER COLLISION & GLASS** · **_Our Team Members Drive Us _**Gerber Collision & Glass is one of the largest collision repair companies in North America. With $2+ billion in sales, over 800 locations and growing, our 10,000+ tea ...
-
Director of Real Estate Education
1 week ago
Harold E. Eisenberg Foundation Northbrook, United States**About Us** · The Harold E. Eisenberg Foundation is a non-profit organization committed to fightinggastrointestinal cancers through advancing cutting-edge medical research. The Foundation is also committed to bolstering the careers of aspiring commercial real estate students thr ...
-
Customs Entry Writer
3 weeks ago
C.H. Robinson Wood Dale, United StatesOur dynamic and comprehensive training program will set you up for success. You will participate in a mix of group activities, self-guided learning, plus coaching and mentoring to help you become an expert in our systems and processes and provide on-going regulatory training. Man ...
-
Senior Clinical Study Manager
1 week ago
Stryker Corporation Cary, United StatesWhy 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 w ...
-
Senior Clinical Study Manager
1 week ago
Stryker Cary, United StatesWhy 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 w ...
-
Warranty Administrator
1 week ago
FIELDS CHRYSLER JEEP DODGE RAM (GLENVIEW) Glenview, United States**Fields Auto Group believes that employees are our greatest asset. As such, we treat all team members with respect and appreciation for their contributions to the company.** · **WHAT WE OFFER** · - ** Medical and Dental**: · - **401(k) Plan**: · - **Competitive wages**: · - **Pe ...
-
Deputy Public Works Director
20 hours ago
Village of Lake in the Hills, IL Lake in the Hills, United StatesSalary: $117,503.00 Annually · Location : Lake in the Hills, IL · Job Type: Full-time · Job Number: · Department: Public Works · Opening Date: 05/14/2024 · Closing Date: 6/4/2024 11:59 PM Central · Summary · The Village of Lake in the Hills Public Works Department is seeki ...
-
Technical Publications Manager
3 weeks ago
ECHO Inc Lake Zurich, United StatesECHO Incorporated is an industry leader in developing and manufacturing high-performance, professional-grade, handheld outdoor power equipment. With distributors and thousands of dealers across North and South America, ECHO is constantly anticipating the future of the outdoor pow ...
-
Mobile Service Technician
1 week ago
Rush Enterprises Huntley, United StatesThe Mobile Mechanic is responsible for maintaining the fleet for clients and to handle service calls at client locations. Provide service to our customers while maintaining exceptional customer service. This can include: cleaning, maintenance, visual inspection, and removal of pa ...
Staff Medical Writer, - Cary, United States - Stryker Corporation
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
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.
About Stryker
Our benefits:
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 atKnow 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.
&v=024){kind=logo}