Sr. Writer, Scientific Operations Technical & Medical Writing at Johnson & Johnson

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at Job Function: Medical Affairs GroupJob Sub Function: Medical WritingJob Category:ProfessionalAll Job Posting Locations:Irvine California United States of America Miami Florida United States of AmericaJob Description:About MedTechFueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions 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 work options may be considered on a case-by-case basis and if approved by the Company.An internal pre-identified candidate for consideration has been identified. However all applications will be considered.We are searching for the best talent for Sr. Writer Scientific Operations Technical & Medical Writing.The Scientific Operations (SciOps) Sr. Writer will provide input and support to related functions ensuring the delivery of key regulatory and medical documents. Specifically the Sr. Writer will lead the review of Clinical Evaluations (CERs) State of the Art Assessments (SOA) Literature Reviews Summaries of Safety and Clinical Performance (SSCP) and Periodic Safety Updates (PSUR) for the MedTech Neurovascular business unit. Furthermore the Sr. Writer will support interactions with the Notified Body and applicable Health Authorities and the drafting and alignment on response strategy and execution.You will provide leadership and maintain relationships through extensive partnering benchmarking and forming strategic alliances with cross functional business partners to drive key business goals and objectives. Additionally you will lead SciOps activities/projects including those supporting the Eudamed Readiness strategies for SSCP and PSURs in support of the EU MDR.Responsibilities:Support a team of managers and medical writers to strategize synthesize and analyze product related safety and performance data draft reports coordinate approvals and when applicable manage submissions to the Notified Body.Perform technical reviews ensuring the accuracy and compliance of Scientific Operations deliverables including Clinical Evaluation Plan (CEP) Clinical Evaluation Report (CER) Literature Review Protocol (LRP) Literature Review Report (LRR) Summary of Safety and Clinical Performance (SSCP) and Periodic Safety Updates Report (PSUR) documents.Track and trend Notified Body inquiries within business unit to identify trends improve processes and increase speed to market. Translate insights into viable processes and solutions that create value.Ensure the Scientific Operations deliverables are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management PMS etc.) to make certain information is consistent and accessible where needed. S/He will develop implement and manage an effective communication model for Scientific Operations deliverables with cross functional business partners.Assist in the development of schedules to ensure operating company deliverable timelines are met.Participate in workshops and lead projects/ initiatives to help define processes globally and keep abreast of MDR regulatory requirements and industry trends/practices ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies.Support audits and inspections pertaining to Scientific Operations processes and reports.Partner with cross-functional business partners such as Medical Directors Post Market Surveillance Design Quality Engineers R&D and Regulatory Affairs relating to the Scientific Operations deliverablesQualifications:RequiredMinimum of a Bachelors degree (University Degree) in Life Sciences Engineering or related subject area.Minimum of 5 years of experience in a regulated environment including 3 years of direct experience with medical devices in the fields of technical or medical writing post market surveillance clinical research or product risk management.Preferred:Knowledge on physiology and common outcomes of neurovascular devicesExperience within the medical device industry and knowledge of clinical evaluation report regulatory requirements evidence generation and CER document creationAn advanced degree MS PhD RN or MBA.Demonstrated knowledge and experience in quality regulatory compliance complaint handling adverse event reporting medical device risk management processes and experience with common bio statistical methodsProcess Excellence / Six Sigma training or certifications.This position can be located remotely or in any one of our MedTech facilities with preferred locations in Irvine CA.Additional Information:The anticipated base pay range for this position is $129000 to $174000.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 corporations performance over a calendar/performance year. Bonuses are awarded at the Companys 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 Companys consolidated retirement plan (pension) and savings plan (401(k)).Employees are eligible for the following time off benefits:Vacation 120 hours per calendar yearSick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar yearHoliday pay including Floating Holidays 13 days per calendar yearWork Personal and Family Time - up to 40 hours per calendar yearParental Leave 480 hours within one year of the birth/adoption/foster care of a childCondolence Leave 30 days for an immediate family member: 5 days for an extended family memberCaregiver Leave 10 daysVolunteer Leave 4 daysMilitary Spouse Time-Off 80 hoursAdditional information can be found through the link below. job posting is anticipated to close on November 28 2025. The Company may however extend this time-period in which case the posting will remain available on to accept additional applicationsJohnson & Johnson is an 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 disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation please email the Employee Health Support Center() or contact AskGS to be directed to your accommodation resource#LI-RemoteRequired Skills:Clinical Research Medical Writing Post Marketing Surveillance Product Risk Management Technical WritingPreferred Skills:Business Writing Clinical Research and Regulations Clinical Trials Operations Coaching Collaborating Communication Copy Editing Data Synthesis Industry Analysis Medical Affairs Medical Communications Problem Solving Process Oriented Proofreading Quality Standards Research Ethics Standard Operating Procedure (SOP)The anticipated base pay range for this position is :$129000 to $174000.Additional Description for Pay Transparency:Required Experience:Senior IC Key Skills Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 129000 - 174000