Senior Medical Writer at Johnson & Johnson
Sr. Medical Writer
- United States
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.
- Incorporates text, graphs, charts, tables, statistical analyses, etc. into clinical documents in a clear and accurate manner with proper formatting.
- Leads, conducts and oversees systematic literature search activities as needed for EU CERs (generating literature search protocols, reviewing/appraising results, summarizing/analyzing pertinent clinical literature) including identification of new risks/hazards relevant to product(s) under evaluation; utilize software to support the core process steps for systematic literature reviews (e.g. Distiller)
- Collects and incorporates available clinical evidence into EU CERs (clinical study outcomes, post-market surveillance data, etc.), post-market clinical reports (PMCRs; for PMS) and EU post-market clinical follow-up (PMCF) reports.
- Communicates with JJV clinical scientists/clinicians, engineers, project managers, regulatory associates, risk management/quality associates, product safety, etc. to obtain and correctly incorporate clinical and technical content into clinical documents; may support one or more R&D project teams with clinical documents for registration of new products.
- Ensures maintenance of EU CEPs/EU CERs and EU CEP/EU CER updates in a document control management system; maintains compliance with EU CER update frequency according to regulations.
- Generates clinical study reports including tracking and maintaining raw data tables/listings from biostatistics, drafting text, formatting tables, compiling final documents, routing and incorporating reviewer edits/comments, etc.
- May work in a team with other clinical research personnel and external medical writers for generation of clinical documents
- Oversees/leads external consultants/projects related to generation of clinical documents as needed
- Acts as team member for generation of PMCF plans with Clinical Science based on assigned therapeutic area and/or products to ensure consistency with EU CER recommendations/clinical evidence needs.
- Ensures document quality by consistently managing and organizing content for accuracy and readability/clarity with proper document formatting and layout.
- Ensures assigned document template maintenance and updates; ensures consistency across JJV business units.
- Works independently with general supervision for timely and accurate document generation
- Proactively identifies areas for improvements/correction and generates potential plans to address the identified need(s).
- Responsible for compliance with applicable Corporate and Divisional Policies and procedures; maintain compliance with applicable state, federal and international regulations.
- Minimum Bachelor’s of Science (BS), preferable in life science, or Registered Nursing degree (RN).
- At least 4 years of experience with generation of clinical research documents or 6 years of general experience in medical/technical writing. Note: Less than 4 years writing experience with advanced degree (M.S. or higher) may be acceptable.
- Approximately 3 years of experience in ophthalmology field is preferred
- Approximately 3 years of experience with medical devices is preferred
- Highly proficient in Microsoft Office Suite (MS WORD in particular) is preferred
- Knowledge/use of bibliographic software use (e.g. Endnote) is preferred
- Demonstrated knowledge of European regulations regarding clinical evaluations for medical devices (EU MDD, MEDDEV 2.7/1 Rev 4, EU MDR) is preferred
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.
- United States—
- Johnson & Johnson Surgical Vision, Inc
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