Johnson & Johnson
Manager Medical Writing
Johnson & Johnson, Irvine, California, United States, 92606
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Johnson & Johnson Vision is recruiting for a Medical Writing Manager, located in Irvine CA, Jacksonville FL, or Milpitas CA.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Medical Writing Manager provides leadership, strategic direction and expertise to meet EU MDR compliance and other clinical research objectives for assigned product area/responsibilities within the J&J Vision sector. Key activities include oversight, planning, generation and timely completion of clinical evaluation deliverables (CEPs, CERs, PMCFERs) and clinical study reports or other clinical documents intended for regulatory submissions. Responsibilities include cross-functional team participation for the development of such clinical documents and direct management/supervision of other medical writers assisting/preparing such clinical documents within the assigned product area.
Primary Responsibilities:
* Responsible for clinical evaluation deliverables for the assigned therapeutic/product area to maintain EU MDR compliance and obtain new product registrations. Responsibilities include:
o Generation of literature search protocols, overseeing literature searches, appraising and analyzing results for both product-specific and state of the art literature within an electronic literature software system
o Generating Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), including assessment of available clinical evidence sufficiency
o Obtaining clinical input and generating PMCF Evaluation Reports (PMCFERs)
o Generating Summary of Safety and Clinical Performance (SSCP) documents for applicable products
o maintaining CEPs and CERs in a document control management system.
* Responsible for clinical study reports and other clinical documents for regulatory submissions and clinical investigations.
o Responsible for clinical study report planning, interpretation of study results and generation of study reports, working closely with clinical science and biostatistics team members.
* Oversees generation of clinical evaluation deliverables and other clinical documents by other clinical research personnel and/or external medical writers.* Provides strategic oversight and guidance on compliant document execution and generation* Role includes management responsibilities for one or more direct reports with coaching/training as needed* Provides input/assistance for Regulatory/ technical documents that include clinical study results (e.g., labelling, summary of safety and effectiveness, instructions for use, etc.).* Participates on cross-functional teams to provide input/assistance with clinical study planning (e.g., PMCF needs/clinical evidence assessment), EU clinical strategy development, etc.* May assist with generation of clinical science publications/manuscripts* Stays current with product regulatory guidance documents; assists with procedure gap assessments* Ensures consistency across J&J Vision business units for clinical research documents. Maintain templates for clinical evaluation documents. Assist/lead procedure updates and template changes as needed.* Provides 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 supports audits from regulatory agencies as necessary.* Enforces company Quality System standards. Ensures document content quality by consistently managing and organizing information for accuracy and readability/clarity.* Responsible for communicating business related issues or opportunities, providing visibility of issues and enabling corrective and preventive action to be taken as needed.* Maintain compliance with corporate policies, state, federal and international regulations.* Performs other duties assigned as needed.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.
Johnson & Johnson Vision is recruiting for a Medical Writing Manager, located in Irvine CA, Jacksonville FL, or Milpitas CA.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.
At Johnson & Johnson, we all belong.
The Medical Writing Manager provides leadership, strategic direction and expertise to meet EU MDR compliance and other clinical research objectives for assigned product area/responsibilities within the J&J Vision sector. Key activities include oversight, planning, generation and timely completion of clinical evaluation deliverables (CEPs, CERs, PMCFERs) and clinical study reports or other clinical documents intended for regulatory submissions. Responsibilities include cross-functional team participation for the development of such clinical documents and direct management/supervision of other medical writers assisting/preparing such clinical documents within the assigned product area.
Primary Responsibilities:
* Responsible for clinical evaluation deliverables for the assigned therapeutic/product area to maintain EU MDR compliance and obtain new product registrations. Responsibilities include:
o Generation of literature search protocols, overseeing literature searches, appraising and analyzing results for both product-specific and state of the art literature within an electronic literature software system
o Generating Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), including assessment of available clinical evidence sufficiency
o Obtaining clinical input and generating PMCF Evaluation Reports (PMCFERs)
o Generating Summary of Safety and Clinical Performance (SSCP) documents for applicable products
o maintaining CEPs and CERs in a document control management system.
* Responsible for clinical study reports and other clinical documents for regulatory submissions and clinical investigations.
o Responsible for clinical study report planning, interpretation of study results and generation of study reports, working closely with clinical science and biostatistics team members.
* Oversees generation of clinical evaluation deliverables and other clinical documents by other clinical research personnel and/or external medical writers.* Provides strategic oversight and guidance on compliant document execution and generation* Role includes management responsibilities for one or more direct reports with coaching/training as needed* Provides input/assistance for Regulatory/ technical documents that include clinical study results (e.g., labelling, summary of safety and effectiveness, instructions for use, etc.).* Participates on cross-functional teams to provide input/assistance with clinical study planning (e.g., PMCF needs/clinical evidence assessment), EU clinical strategy development, etc.* May assist with generation of clinical science publications/manuscripts* Stays current with product regulatory guidance documents; assists with procedure gap assessments* Ensures consistency across J&J Vision business units for clinical research documents. Maintain templates for clinical evaluation documents. Assist/lead procedure updates and template changes as needed.* Provides 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 supports audits from regulatory agencies as necessary.* Enforces company Quality System standards. Ensures document content quality by consistently managing and organizing information for accuracy and readability/clarity.* Responsible for communicating business related issues or opportunities, providing visibility of issues and enabling corrective and preventive action to be taken as needed.* Maintain compliance with corporate policies, state, federal and international regulations.* Performs other duties assigned as needed.