Clinical Research/Medical Writer in Mahwah, NJ at Stryker Corporation

Date Posted: 8/28/2018

Job Snapshot

Job Description

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***REMOTE BASED POSITION***As a Clinical Research/Medical Writer you will contribute to the management and completion of Clinical Evaluation Reports for the Joint Replacement Division at Stryker. You will also be responsible for providing clinical data support for Technical Documentation and submissions for Design Examination Certificates and country-specific device registrations, and responding to questions from global Regulatory Bodies. We are looking for an ambitious, team oriented candidate with strong analytical, technical writing and communication skills. The ideal Clinical Regulatory Specialist candidate will strive for excellence in analyzing and communicating clinical data support, with the primary goal of maintaining market access for Stryker’s products.  Responsibilities include:



  • Prepare and analyze clinical data, journal articles and scientific presentations, as applicable, to support regulatory submissions

  • Manage one or more post-approval, post-market surveillance clinical trials

  • Develop clinical plan strategies and assist in the execution of clinical study protocols, timelines, and budget management

  • Collaborate with Regulatory and Quality Affairs on clinical data analysis and post-market surveillance

  • Support Marketing functions in strategic clinical data needs

  • Ensure compliance of clinical trials with federal and applicable regulatory agency requirements, Good Clinical Practices, and Standard Operating Procedures

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Qualifications:



  • 5+ years of experience as a Clinical Research Associate, Clinical Project Manager or equivalent external position

  • Experience in the medical device field preferred; experience in the pharmaceutical industry considered

  • Demonstrated clinical regulatory experience including knowledge of applicable US and OUS regulations and clinical data requirements, and preparation of clinical sections of regulatory submissions for FDA and international agencies.

  • Applied knowledge of project management tools

  • Demonstrated interpersonal, written and oral communication skills

  • Demonstrated organization and planning skills

  • Demonstrated success in a team-based environment preferred

  • Demonstrated knowledge and application of personal computer systems and desktop applications

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Work From Home: No

Travel Percentage: None

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.

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