Staff Medical Writer (Remote)
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Job Location:
Fremont, CA - USA
Monthly Salary:
$ 87600 - 186700
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Stryker is currently seeking a Staff Medical Writer to join our Neurovascular Division to be based in Fremont CA or remotely anywhere within the United States.
What you will do
As 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 support 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.
Assist in the maintenance of the Stryker Endoscopy library for all relevant literature.
Assist in the process improvements for the medical writing team.
What you need
Required
Bachelors Degree preferably in a Scientific Discipline
4 years of combined experience in healthcare or medical devices
2 years of previous medical writing experience in a healthcare product or medical device industry
Strong scientific and medical writing skills
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.
Preferred
Master of Science Degree or Ph.D./ Pharm. D./M.D.
Experience with MEDDEV 2.7/1 Rev. 4 and EU Medical Device Regulation 2017/745 (MDR) compliant clinical evaluations
Knowledge in clinical operations risk management regulatory submissions and US and international guidelines
Ability to apply ISO FDA and related guidelines toward writing strategy and documentation
$87600 - $186700 salary plus bonus eligible benefits. Individual pay is based on skills experience and other relevant factors.
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 contractors legal duty to furnish information.Required Experience:
Staff IC
Key Skills
- Photography
- Proofreading
- Fact check
- Interviewing
- AP Style
- Journalism
- SEO
- Copywriting
- Creative Writing
- Wordpress
- Blogging
- Writing Skills
About Company
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. Alongsid ... View more
