Manager Medical Writing, Clinical Research
Location:
, California
Posted:
April 01, 2017
Reference:
AMO30031674-en-us

Johnson & Johnson Vision, part of the Johnson & Johnson Family of Companies, is currently recruiting for a Manager Medical Writing, Clinical Research, located in Santa Ana, California.

 

Johnson & Johnson Vision is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and consumer eye health and now serves more than 60 million patients a day across 103 countries with its eye health portfolio. Thriving on a diverse company culture, celebrating the uniqueness of our employees, and committed to inclusion. Proud to be an equal opportunity employer.

The Manager Medical Writing, Clinical Research will work on cross-functional teams to provide input/assistance with clinical study protocols, protocol amendments, clinical investigator brochures, statistical plans, and regulatory submissions and responses.  Responsible for clinical study reports, clinical evaluation reports, scientific publications (abstracts, manuscripts, scientific presentations.), clinical trial results reporting.  Provide input/assistance for Regulatory/ technical documents that include clinical study results (e.g., labeling, summary of safety and effectiveness, instructions for use, etc.).  

 
The Manager Medical Writing, Clinical Research will:
  • Do clinical study report planning.
  • Interpretation of study results and generation of study reports for assigned product responsibilities. 
  • Coordinates with Biostatistics to obtain necessary data tables and listings for clinical study reports. 
  • Responsible for clinical evaluation reports for assigned product responsibilities by conducting literature searches, evaluating and assessing scientific literature and available clinical evidence (clinical study outcomes, post-market surveillance data, etc.), providing clinical input to post-market surveillance reports (post-market clinical reports, i.e., PMCRs),
  • Participating in cross-functional post-market surveillance meetings for risk assessment updates, and maintaining CERs and CER updates in a document control management system .
  • Provide input into case report form design (e.g., EDC) and data collection methods for reporting purposes.
  • Maintain compliance with state, federal and international regulations. Ensure consistency across divisional business units for clinical research documents and testing procedures (protocols, clinical study reports, etc.). 
  • Maintain templates for clinical documents including test methodology instructions. Provide input for project budget planning when external medical writers/technical editors are utilized. 
  • May assist in selecting providers, managing vendor contracts, and ensuring expenditures are within budgetary guidelines. Participates in and support audits from regulatory agencies as necessary. 
  • Ensure document content quality by consistently managing and organizing information for accuracy and readability/clarity.

Qualifications

Required
 

  • BA/BS degree.  Advanced degree preferred
  • At least 5 years of experience writing clinical research documents
  • May consider less experience with advanced degree
  • Adept in Microsoft WORD


Primary Location
United States-California-
Organization
Abbott Medical Optics, Inc. (6233)
Job Function
R&D
Requisition ID
AMO30031674

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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