Remote Jobs: Senior Regulatory Writing Specialist

Kelly Services

  • Fort Worth, TX


  • Permanent

  • Full-time

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a Senior Regulatory Writing Specialist at a prestigious Fortune 500® company working in Fort Worth, TX.

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “Submit Resume” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( ) however your resume must be received via the “Submit Resume” button included within.

Job Title: Senior Regulatory Writing Specialist

  • This can be a remote role located in the US

Role Overview:

The Senior Regulatory Writing Specialist partners directly with Global Regulatory, connects and supports project teams across multiple compound and/or projects to ensure the development of high-quality, message-focused, submission-ready, regulatory documents. The incumbent is responsible for the preparation of key regulatory documents for submission to global Health Authorities. This role is expected to exhibit organizational and project management skills consistent with level and to work cross-functionally with a high degree attention to detail and prompt response in a fast-paced work environment.

Responsibilities

  • Collaborates with regulatory project lead to establish document key messages, timelines, and priorities
  • Plans, writes, edits, and reviews regulatory documents such documents include, among others, meeting requests/briefing documents, Common Technical Document Modules 2-5, 510(k), and Health Authority responses
  • Ensures document quality regarding agreed upon key messages, compliance with Standard Operating Procedures (SOPs) and Health Authority guidance, and consistency with applicable style guides and document conventions
  • Provides guidance to project team members unfamiliar with or inexperienced in regulatory document requirements

Education:

  • Minimum of a Bachelor’s degree with regulatory or medical writing experience in the pharmaceutical/biotechnology/medical device industry
  • Minimum of 7 years of drug/biologics/device development experience with a minimum of 5 years’ experience in the development of regulatory documents for Health Authority submission

Competencies:

  • Experience in assembling scientifically complex data or information to support Key Messages; able to convert relevant data and information into a form that meets clinical regulatory document requirements and audience needs.
  • Experience leading teams, fostering cross-functional collaboration, and managing complex projects with multiple inputs
  • Excellent written communication skills; demonstrated attention to detail; strong interpersonal skills; and tactful negotiation and influencing skills
  • Easily adapts to changing priorities; able to propose solutions to complex problems
  • Ability to effectively handle conflict through proactive action and direct and timely communication
  • Ability to efficiently prepare clinically focused regulatory documents as part of a multi-disciplinary document authoring team
  • Knowledge of EDMS systems, regulatory publishing, and preparation of regulatory submissions
  • Demonstrated expertise with Microsoft Office programs and document templates

*Travel Requirements: 10% Local to Fort Worth, TX

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Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

Why Kelly®?

With Kelly, you’ll have access to some of the world’s highest regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.

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. 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 is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity.

Kelly Services


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