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Clinical Science Program Manager

8.00 to 13.00 Years   Gurugram   10 Dec, 2019
STRYKER CORPORATION
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

You will represent Stryker Neurovascular as the subject matter expert within department for the Global product portfolio developing and maintaining in- depth therapeutic and product operation knowledge.

Your main job responsibilities are:

  • Serves as medical writing lead on clinical regulatory documents such as those associated with filings and dossiers, including writing and maintaining Clinical Evaluation Reports. Works closely with the Clinical and Regulatory team(s) on document strategies.
  • Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects.
  • Collaborates (writing, reviewing, editing and approval) with clinical, RD, quality assurance, safety, regulatory and marketing teams on clinical study reports, clinical evidence gap assessments, marketing collaterals, PMCF reports and other documents that require the evaluation of clinical data and/or clinical literature.
  • Performs literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to scientific publications or clinical regulatory documents.
  • Understands, assimilates, and interprets sources of information 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.

What you need

  • MS or PhD in engineering, biological or life sciences, or Master s in Public Health, PMP/PgMP preferred
  • 5- 8+ years of progressively increasing responsibility in clinical, medical writing or scientific field
  • Medical device industry experience strongly preferred
  • Experience of team management preferred
  • Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of global clinical studies, as well as preparation of clinical documentation in support of regulatory submissions
  • Direct experience with medical and/or scientific writing within a medical device industry or related industry including preparation of Clinical evaluation reports and post market surveillance reporting.
  • Applied knowledge of project management tools
  • Demonstrated success in a team- based environment.
  • Demonstrated interpersonal, written and oral communication skills.
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Keyskills :
project managementagile program managementmanagement deliverypost market surveillance life sciencespublic health

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