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Kelly Services Technical Writer in Raynham, Massachusetts

Technical Writer: Regulatory Affairs

Reports to: Senior Manager Regulatory Affairs

Job Purpose

  • To support Technical Writing by preparing and processing change orders (CO) to meet regulatory compliance.

  • Works with instructions for use (IFU) Coordinator to meet IFU requirements for base business and new product development and ROW compliance.

  • Provides administrative support for IFU traceability and IFU special projects. Working with Regulatory Affairs, Technical Writer, and project Teams to develop information for new IFUs.

Principal Accountabilities

  • IFU editing includes working with teams to redline existing IFUs for changes to be processed, and managing technical reviews of IFU drafts

  • Windchill Change order processing includes preparing correct documentation for routing IFUs through the Change Order process

  • Provides administrative support for IFU traceability and IFU special projects

  • Enters, maintains, and validates IFU Database

Internal And External Relationships

  • Manage priorities for their team with project leaders

  • Co-ordinates appropriate actions within JNJ process and Windchill

  • Execute with partners in labeling and projects teams (LCM (life cycle management)/base business or RD)

Qualifications And Experience

  • Bachelor’s degree or higher

  • Basic understanding of compliance / regulatory requirements is not a requirement but preferred.

  • Technical Writing and editing

  • Strong analytical skills (creating and following procedures) and solving procedural roadblocks

  • Flexibility – able to adapt to compliance cycle activities and demanding timelines

  • Strong team player – will need to collaborate with Regulatory Affairs teams, in addition to other cross-functional team members

  • Excellent written and verbal communication and the ability communicate effectively with all levels of the organization

  • Familiarity with document or content management systems concepts a plus

SPECIFIC COMPETENCIES

  • Excellent planning and organizational skills

  • Time management

  • Communication – listener, learner, and thinker

  • Thorough and flexible

  • Cross culturally aware

  • Team player

  • Enthusiastic and committed.

Open to remote work for the right candidate.

You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly ®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

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