Senior Writer – MedTech Surgery

Content WriterContent WriterFull TimeRemoteTeam 10,001+Since 1886H1B SponsorCompany SiteLinkedIn

Location

New Jersey

Posted

3 days ago

Salary

$109K - $174.8K / year

Bachelor Degree4 yrs expEnglish

Job Description

• 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. • Responsible for communicating business related issues or opportunities to next management level.

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 period10 days
  • Volunteer Leave – 32 hours per calendar year
  • Military Spouse Time-Off – 80 hours per calendar year

Related Categories

Related Job Pages

More Content Writer Jobs

Full TimeRemoteTeam 10,001+

Senior Writer for MedTech Surgery developing clinical documents and reports

New Jersey
$109K - $174.8K / year

Freelance English Writer - AI Trainer

Mindrift

Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid. Project time expectations: Tasks are estimated to require around 10–20 hours per week during active phases, based on project requirements; This is an estimate, not a guaranteed workload, and applies only while the project is active. Note: Rates vary based on expertise, skills assessment, location, project needs, and other factors. Higher rates may be offered to highly specialized experts. Lower rates may apply during onboarding or non-core project phases. Payment details are shared per project.

Content Writer3 days ago
Part TimeRemote

Please submit your resume in English and indicate your level of English proficiency.Mindrift connects specialists with project-based AI opportunities for leading tech companies, focused on testing, evaluating, and improving AI systems. Participation is...

Iowa

Freelance English Writer - AI Trainer

Mindrift

Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid. Project time expectations: Tasks are estimated to require around 10–20 hours per week during active phases, based on project requirements; This is an estimate, not a guaranteed workload, and applies only while the project is active. Note: Rates vary based on expertise, skills assessment, location, project needs, and other factors. Higher rates may be offered to highly specialized experts. Lower rates may apply during onboarding or non-core project phases. Payment details are shared per project.

Content Writer3 days ago
Part TimeRemote

Please submit your resume in English and indicate your level of English proficiency.Mindrift connects specialists with project-based AI opportunities for leading tech companies, focused on testing, evaluating, and improving AI systems. Participation is...

Colorado

Freelance English Writer - AI Trainer

Mindrift

Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid. Project time expectations: Tasks are estimated to require around 10–20 hours per week during active phases, based on project requirements; This is an estimate, not a guaranteed workload, and applies only while the project is active. Note: Rates vary based on expertise, skills assessment, location, project needs, and other factors. Higher rates may be offered to highly specialized experts. Lower rates may apply during onboarding or non-core project phases. Payment details are shared per project.

Content Writer3 days ago
Part TimeRemote

Please submit your resume in English and indicate your level of English proficiency.Mindrift connects specialists with project-based AI opportunities for leading tech companies, focused on testing, evaluating, and improving AI systems. Participation is...

Arizona