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Senior Writer – MedTech Surgery

Content WriterContent WriterOtherRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

New Jersey

Posted

102 days ago

Salary

$109K - $174.8K / year

Seniority

Senior

Bachelor Degree4 yrs expEnglish

Job Description

Senior Writer – MedTech Surgery

Johnson & Johnson

• 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.

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

  • 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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