& 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,
- 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.
degree. Advanced degree preferred
- At least 5 years of experience writing clinical research
- May consider less experience with advanced degree
- Adept in Microsoft WORD
Abbott Medical Optics, Inc. (6233)Job Function