Staff Specialist, Medical Writer in San Jose, CA at Stryker Corporation

发布日期: 10/20/2019



As a Staff Specialist, Medical Writer, you will serve as a medical writer by compiling clinical evidence from 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) in support of EU- MDR submissions, required CEPs, and annual updates. Primary responsibilities include:

  • Serves as medical writing lead on clinical regulatory documents such as those associated with filings and dossiers. Works closely with the Clinical and Regulatory team(s) on document strategies.
  • Serves as a subject matter expert within department. Recognizes potential scheduling and resource conflicts for projects and provides recommendations to resolve.
  • Understands, assimilates, and interprets sources of info with appropriate guidance/direction from product teams and/or authors. Interprets and explains data generated from a variety of sources, including internal/external studies, research documentation, charts, graphs, and tables. Verifies that results are consistent with protocols. Confirms completeness of information to be presented. Challenges conclusions when necessary. Independently resolves document content issues and questions.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents.
  • Partners with Clinical/Regulatory in developing Clinical EU-MDR process and procedures and in developing a project plan for Clinical EU-MDR documentation.
  • Collaborates cross-functionally to provide input for design teams for Clinical EU MDR documentation.

What you need

  • Bachelors of Science degree, scientific discipline preferred
  • 6+ years relevant clinical research experience in the healthcare industry
  • Medical writing experience required
  • Knowledgeable 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

You may also have

  • Advanced degree preferred
  • Ability to complete complex tasks using creativity, personal experience and good judgment
  • Ability to work independently and cross-functionally
  • Demonstrated ability to solve problems, troubleshooting, and organize priorities
  • Must be results oriented, a quick learner, and able to respond to the urgent needs of the team ensuring all deadlines are met
  • Excellent analytical,writing skills, critical thinking and problem solving skills
  • Effective interpersonal communication skills

Work From Home: Yes

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.