Sr. Medical Writer
Responsible for generation and/or updates of complex clinical science documents containing clinical and technical data in support of JJV medical device product lines.
Clinical science documents include EU clinical evaluation plans (CEPs), EU clinical evaluation reports (CERs), EU post-market clinical follow-up (PMCF) evaluation reports, EU Summaries of Safety and Clinical Performance (SSCPs; as applicable), Clinical Science clinical study reports, scientific publications, and other clinical documents for regulatory submissions, clinical investigations and other key clinical science needs. Communicates with other writers, clinical scientists/clinicians, engineers, project managers, regulatory associates, risk management/quality associates, product safety etc. to obtain and appropriately incorporate clinical and technical content to generate clinical documents. Ensures quality and accuracy of documents, document format and layout. Ensures assigned document template maintenance and updates. Works independently with minimal supervision.
Ensures compliance with company policies/procedures, state, country and international regulations.
Essential Functions / Responsibilities
Responsible for the generation and/or update(s) of EU clinical evaluation plans (CEPs), EU clinical evaluation reports (CERs), EU post-market clinical follow-up (PMCF) evaluation reports, EU Summaries of Safety and Clinical Performance (SSCPs; as applicable), Clinical Science clinical study reports (CSRs), scientific publications (abstracts, manuscripts, scientific presentations.), and other clinical documents (e.g. labelling) for regulatory submissions in assigned therapeutic area and/or products.
Position is REMOTE.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Tagged as: 501+ Employees