Senior Writer, Scientific Operations – Technical & Medical Writing
Johnson & Johnson
full-time
Posted on:
Location Type: Remote
Location: Remote • California, Florida • 🇺🇸 United States
Visit company websiteSalary
💰 $129,000 - $174,000 per year
Job Level
Senior
About the role
- 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.
- 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 deliverables.
Requirements
- Minimum of a Bachelor’s 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.
- Knowledge on physiology and common outcomes of neurovascular devices
- Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation
- An 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 methods
- Process Excellence / Six Sigma training or certifications.
Benefits
- medical insurance
- dental insurance
- vision insurance
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- retirement plan (pension)
- savings plan (401(k))
- vacation –120 hours per calendar year
- sick time - 40 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
- Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
- Caregiver Leave – 10 days
- Volunteer Leave – 4 days
- Military Spouse Time-Off – 80 hours
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
technical writingclinical evaluation report (CER)clinical evaluation plan (CEP)literature review protocol (LRP)literature review report (LRR)summary of safety and clinical performance (SSCP)periodic safety updates report (PSUR)risk managementpost market surveillancebiostatistical methods
Soft skills
communicationstrategic thinkingprocess improvementproject managementcollaborationanalytical skillsproblem-solvingleadership
Certifications
Process ExcellenceSix Sigma