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Senior Writer – MedTech Surgery
Location
New Jersey
Posted
101 days ago
Salary
$109K - $174.8K / year
Seniority
Senior
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. • 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
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• 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.
Freelance English Writer - AI Trainer
MindriftApply → 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.
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 isproject-based, not permanent employment. What this opportunity involves As an AI Trainer - Writer, your work will help train AI models, shaping how they understand and generate human-like text. This isn’t just traditional writing—you’ll be crafting text that teaches AI reasoning, logic accuracy, nuance, and clarity. While each project involves unique tasks, contributors may: - Crafting original, clear, and fact-checked responses based on project guidelines. - Following style and quality standards to ensure consistency. - Collaborating with Quality Assurance Specialists to refine and improve content. What we look for This opportunity is a good fit if you are seeking for open to part-time, non-permanent projects. Ideally, contributors will have: - Bachelor’s degree in any subject field; - At least 1 year of professional or educational experience in any field; - Strong written English (C1/C2); - Stable internet connection. How it works Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid Project time expectations For this project, 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. Compensation On this project, contributors can earn up to $30 per hour equivalent, depending on their level and pace of contribution. Compensation varies across projects depending on scope, complexity, and required expertise. Please note that other projects on the platform may offer different earning levels based on their requirements.
Freelance English Writer - AI Trainer
MindriftApply → 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.
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 isproject-based, not permanent employment. What this opportunity involves As an AI Trainer - Writer, your work will help train AI models, shaping how they understand and generate human-like text. This isn’t just traditional writing—you’ll be crafting text that teaches AI reasoning, logic accuracy, nuance, and clarity. While each project involves unique tasks, contributors may: - Crafting original, clear, and fact-checked responses based on project guidelines. - Following style and quality standards to ensure consistency. - Collaborating with Quality Assurance Specialists to refine and improve content. What we look for This opportunity is a good fit if you are seeking for open to part-time, non-permanent projects. Ideally, contributors will have: - Bachelor’s degree in any subject field; - At least 1 year of professional or educational experience in any field; - Strong written English (C1/C2); - Stable internet connection. How it works Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid Project time expectations For this project, 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. Compensation On this project, contributors can earn up to $30 per hour equivalent, depending on their level and pace of contribution. Compensation varies across projects depending on scope, complexity, and required expertise. Please note that other projects on the platform may offer different earning levels based on their requirements.
Freelance English Writer - AI Trainer
MindriftApply → 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.
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 isproject-based, not permanent employment. What this opportunity involves As an AI Trainer - Writer, your work will help train AI models, shaping how they understand and generate human-like text. This isn’t just traditional writing—you’ll be crafting text that teaches AI reasoning, logic accuracy, nuance, and clarity. While each project involves unique tasks, contributors may: - Crafting original, clear, and fact-checked responses based on project guidelines. - Following style and quality standards to ensure consistency. - Collaborating with Quality Assurance Specialists to refine and improve content. What we look for This opportunity is a good fit if you are seeking for open to part-time, non-permanent projects. Ideally, contributors will have: - Bachelor’s degree in any subject field; - At least 1 year of professional or educational experience in any field; - Strong written English (C1/C2); - Stable internet connection. How it works Apply → Pass qualification(s) → Join a project → Complete tasks → Get paid Project time expectations For this project, 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. Compensation On this project, contributors can earn up to $30 per hour equivalent, depending on their level and pace of contribution. Compensation varies across projects depending on scope, complexity, and required expertise. Please note that other projects on the platform may offer different earning levels based on their requirements.
