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Staff Medical Writer – Remote

Stryker

This is a Full-time position in Remote - US posted April 12, 2021.

Location: Remote – US

We are currently seeking a Staff Medical Writer to join our Extremities division to be based in Columbia City, IN preferred or remotely anywhere within the United States.

Who we want

  • Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
  • User-focused creators. People who imagine with the user in mind, developing technology that helps change patients’ lives.

What you will do

As the Staff Medical Writer you will develop and create Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation and US FDA requirements. You will be part of the creation of Clinical Evaluation Reports, analysis of product complaints and trends, Post-Market Surveillance, conducting literature reviews, and collecting and summarizing feedback from all sources such as media, sales force, and competitors’ websites. You will conduct Post-Market Surveillance activities by interfacing with project teams, internal and external personnel, and governmental regulatory agencies.

  • Perform scientific writing (e.g. abstracts, manuscripts, presentations) necessary for new product market clearance, approval and continuance during product life cycle management that includes (but is not limited to) Post-Market Surveillance Plans (PMSP), Post-Market Surveillance Reports (PMSR), Clinical Evaluation Reports (CER), Periodic Safety Update Reports (PSUR), Summaries of Safety and Clinical Performance (SSCP), supplements, technical files and design dossiers for CE mark. Manages the collection of information required by subsidiaries or distributors to support international regulatory body product approval/ licensing.
  • Monitor proposed and current global regulations and guidance and advises on impact of such regulations and guidance on the company.
  • Provide support to the Regulatory Affairs Department in providing information for various regulatory filings and inquiries from Notified Bodies and government agencies.
  • Participate in post-market surveillance activities by conducting routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria, extracts data from included studies, interprets study results, synthesizes literature, and prepares summaries into formal reports) for specific medical device groups or sub-groups.
  • Knowledge of clinical research, device/drug development processes, regulatory requirements, good clinical and data management practices.
  • Ensure documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1), and electronic templates, including scheduling and facilitating team meetings and follow-up actions.
  • Primarily focus on preparing, writing, editing, and reviewing regulatory documents (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries).

What you need

  • A Bachelor’s Degree engineering, life sciences or equivalent technical field required.
  • A minimum of 4 years of medical or scientific writing experience required.
  • Scientific/clinical background with experience in clinical or regulatory affairs preferred.
  • Experience with medical devices and/or orthopedics preferred.
  • Current knowledge of FDA medical device regulations, EU Medical Device Regulations, Health Canada preferred.
  • Extensive knowledge of FDA and applicable international regulations and standards preferred.
  • Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
  • Ability to write, review, and provide training on detailed technical regulatory submissions, reports, and business correspondence.
  • Excellent verbal and written communications focused on scientific or technical communications.
  • Strong leadership, project management, and ability to work with cross functional groups and geographies.
  • Ability to effectively present information to other employees, management, and regulatory agencies.

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.

  • Full time
  • Work From Home: Remote
  • Travel Percentage: 10%
  • R447451