Senior Medical Writer

Johnson & Johnson Innovative Medicine • Warsaw, IN

1d • Remote

About The Position

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. 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. 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 Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness.

Requirements

• Minimum of a Bachelor’s degree and/or University degree is required.
• 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.

Nice To Haves

• Advanced degree is preferred.
• 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.

Responsibilities

• Provides oversight and execution of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Orthopedics.
• Supports broader initiatives and general Scientific Operations activities to support the continuous process improvement activities of the Scientific Operations Team.
• Conducts technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines and regulatory requirements.
• Manages daily activities to ensure timelines are met.
• Participates in workshops and other initiatives to help define and continuously improve process efficiency.
• Participates in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices.
• Supports interactions with respective Notified Bodies and regulatory agencies.
• Supports audits and inspections pertaining to SciOps processes and deliverables.
• Actively partners 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 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.

Benefits

• Employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• This position is eligible to participate in the Company’s long-term incentive program.
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees