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Senior Medical Writer, Clinical Science.

Company: Johnson & Johnson
Location: Santa Ana
Posted on: January 13, 2022

Job Description:

Johnson & Johnson Vision, is currently recruiting for a Senior Medical Writer, Clinical Science

At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That's why, through our operating companies, we've developed solutions for every stage of life-to help people see better, connect better and live better. We partner with eye care professionals to provide some of the world's leading products and technologies to address refractive error, cataracts, dry eye, and beyond. We are committed to using our reach and size for good, and strive to put quality eye care within reach of everyone, everywhere. Visit us at www.jjvision.com. Follow @JNJVision on Twitter and Johnson & Johnson Vision on LinkedIn.

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.

Qualifications
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

At Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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.

Primary Location

United States-California-Santa Ana-1700 E Saint Andrew Place

Organization

Johnson & Johnson Surgical Vision, Inc (6234)

Job Function

R&D

Requisition ID

2105988296W

Keywords: Johnson & Johnson, Santa Ana , Senior Medical Writer, Clinical Science., Healthcare , Santa Ana, California

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