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.
Senior Writer - MedTech Surgery
Location
United States
Posted
5 days ago
Salary
$109K - $174K / year
No structured requirement data.
Job Description
Role Description
About Surgery: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease, and cancer. Patients are waiting.
Your unique talents will help patients on their journey to wellness.
We are searching for the best talent for a Senior Writer to support our Surgery business. Remote work options may be considered on a case-by-case basis and if approved by the Company. There is a strong preference for candidates in Eastern or Central time zones.
Purpose: The Sr. Writer provides oversight and execution of Clinical Evaluation Reports/Plans (CER/CEP) and Summary of Safety and Clinical Performance Reports (SSCP). Activities also include oversight and planning of systematic literature reviews for the generation of CERs, Post-Market Surveillance, FDA Reports, and State of the Art (SOA) for Ethicon within J&J Global R&D Medical Device sector.
You will be responsible for:
- Planning, writing, and reviewing CEPs, CERs (including State of the Art protocols and reviews), Literature reports, and SSCPs
- Reviewing and editing scientific writing to ensure document accuracy and compliance to local procedures, J&J guidelines, and regulatory requirements
- Mentoring junior writers
- Supporting responses to queries from regulatory bodies (e.g. Notified Bodies)
- Utilizing software to support the core process steps for systematic literature reviews including statistical analysis tools (e.g. Distiller, Readcube)
- Advising on project-specific software tool designs (e.g. data management systems) to house clinical study data from literature
- Partnering with cross-functional team members to address needs of each contributor
- Leading daily activities to ensure timelines are met
- Participating in workshops and other initiatives to help define and continuously improve process efficiency
- Participating in continuing education activities to improve understanding of associated regulatory requirements and industry trends/practices
- Supporting and, at times, acting as a subject matter authority during audits and inspections pertaining to processes and reports
- Responsible for communicating business-related issues or opportunities to next management level
- For those who supervise or manage staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
- Responsible for personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Performs additional assigned duties as needed
Qualifications
- Minimum of a Bachelor’s Degree is required; Advanced Degree is strongly preferred
- At least 4+ years of related experience is required
- Experience within the medical device and/or pharmaceutical industry and knowledge of global clinical evaluation regulatory requirements, document creation, and associated evidence generation is required
- Strong verbal communication skills and interpersonal relationships
- Proven knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred
Benefits
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
Job Requirements
- Minimum of a Bachelor’s Degree is required; Advanced Degree is strongly preferred
- At least 4+ years of related experience is required
- Experience within the medical device and/or pharmaceutical industry and knowledge of global clinical evaluation regulatory requirements, document creation, and associated evidence generation is required
- Strong verbal communication skills and interpersonal relationships
- Proven knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting, medical device risk management process, and common statistical methods is preferred
Benefits
- Vacation – 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year
- Holiday pay, including Floating Holidays – 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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