Senior Writer – MedTech Surgery
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Job Description
Senior Writer for MedTech Surgery developing clinical evaluation and safety reports for innovative surgical technologies. Collaborating with cross-functional teams in the medical device sector at Johnson & Johnson.
Responsibilities:
- 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.
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:
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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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