Manager Medical Writing_

Manager Medical Writing - 2406205018W**Description**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 nj.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 nj.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 systemo Generating Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs), including assessment of available clinical evidence sufficiencyo Obtaining clinical input and generating PMCF Evaluation Reports (PMCFERs)o Generating Summary of Safety and Clinical Performance (SSCP) documents for applicable productso 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.**Qualifications*** Minimum of a Bachelor’s Degree is **required** ; Advanced Degree _strongly preferred_ .* Minimum of 6 years of relevant job experience **required** .* Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, and Clinical Evaluation Report (CER) document creation is **required** .* Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is _preferred_ .* Management experience is _preferred_* Able to understand and interpret statistical results of clinical studies and understands good data management practices.* Adept at Microsoft WORD; Distiller SR literature software experience is _preferred_* Strong oral communication, presentation, project management and prioritization skills* Excellent interpersonal relationships.* Position is a hybrid work schedule.* Up to 10% Domestic and International Travel may be required.This job posting is anticipated to close on 9/4/2024. The Company may however extend this time-period, in which case the posting will remain available on areers.jnj.com to accept additional applications.The anticipated base pay range for this position is 113000 to 195500. California Bay Area - The anticipated base pay range for this position is 139000 to 224825.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits:Vacation – up to 120 hours per calendar yearSick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar yearHoliday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar yearAdditional information can be found through the link below. areers.jnj.com/employee-benefitsThe compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."**Primary Location** NA-US-California-Milpitas**Other Locations** NA-US-Florida-Jacksonville, NA-US-California-Irvine**Organization** Johnson & Johnson Surgical Vision, Inc (6234)**Job Function** Medical Writing**Req ID:** 2406205018W