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 Medical Writer
Location
United States
Posted
57 days ago
Salary
$109K - $174.8K / year
Seniority
Senior
No structured requirement data.
Job Description
Senior Medical Writer
Johnson & Johnson Innovative Medicine
Role Description We are searching for the best talent for a Senior Medical Writer, Scientific Operations, to join our MedTech Team. Remote work options may be considered on a case-by-case basis and if approved by the Company. The Senior Medical Writer, Scientific Operations provides oversight and execution of: - Clinical Evaluation Reports (CER) - Summary of Safety and Clinical Performance Reports (SSCP) - State of the Art Reviews (SOA) - Systematic Literature Reviews (LRR) They also support broader initiatives and general Scientific Operations activities to support the continuous process improvement activities of the Scientific Operations Team. Key Responsibilities - Planning and writing CERs, SSCPs, SOAs, and LRRs as well as mentoring other writers. - Conducting technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines, and regulatory requirements. - Managing daily activities to ensure timelines are met. - Participating in workshops and other initiatives to help define and continuously improve process efficiency. - Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices. - Supporting interactions with respective Notified Bodies and regulatory agencies. - Supporting audits and inspections pertaining to SciOps processes and deliverables. - Actively partnering with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs. - Responsible for communicating business-related issues or opportunities to the next management level. - Responsible for following all Company guidelines related to Health, Safety, and Environmental practices as applicable. - Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures. - Performs other duties assigned as needed. Qualifications - Minimum of a Bachelor’s degree and/or University degree is required. Advanced degree is preferred. Requirements - A minimum of four (4) years of experience in a related, professional environment. - Strong oral communication, presentation, project management, and prioritization skills. - Excellent interpersonal relationships. Preferred Qualifications - Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, literature reviews, and/or Clinical Evaluation Report (CER) document creation. - Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting. - Previous experience in orthopedics, specifically joint reconstruction and/or spine. Other Requirements - May require up to 10% domestic and/or international travel to other locations and sites. - This is a remote position. Benefits - Base pay range: $109,000.00 - $174,800.00. - Eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). - Eligible to participate in the Company’s long-term incentive program. - Vacation: 120 hours per calendar year. - Sick time: 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents. - 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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