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Cardinal Health Regulatory Technical Writer in Massachusetts

The Regulatory Technical Writer (RTW) plays an important role in the Regulatory Affairs department supporting regulatory document writing to develop the global evidence base for company development programs. RTW is responsible for providing support to Global Regulatory Affairs (GRA) team for all submission needs. The Writer in this position will develop documents required to facilitate global regulatory programs by incorporating an understanding of the clinical development program, relevant scientific literature, and regulatory goals to drive scope and direction of data-driven summaries.

What Medical Writing bring to Cardinal Health:

  • Prepare, write, edit and review high-quality regulatory documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. This includes but is not limited to 510(k)s, Pre-Market Approval (PMA) submissions and PMA Supplements, EU Technical Documentation Files and Global STEDs, Pre-Submission meeting packages to agencies, responses to regulatory agency requests, annual reports.
  • Provide support for the preparation and submission of critical regulatory documents and responses to health authority information requests using available reference materials, scientific literature, and content provided by the Global Regulatory Affairs (GRA) team members & functional area contributors.
  • Ensure accurate and timely completion/delivery of information and review of regulatory submissions. Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members.
  • Work closely with team members on the strategic content of target documents.
  • Collaborate with project teams and functional area contributors to advance global regulatory programs and product development projects.
  • Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRA team and/or authors/key opinion leaders. Ensure required documentation is obtained.
  • Explain and prepare data in manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
  • Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Resolve document content issues and questions arising during the writing process.
  • Assist in the design and implementation of tactical process improvements.

Qualifications:

  • BA, BS or equivalent experience in related field Advance Degree may be required
  • 8-12 years of experience
  • A Covid-19 vaccination is required in order to be employed in this position. This includes either:

  • 2 doses of the Moderna or Pfizer vaccine

  • 1 dose of the Johnson & Johnson vaccine

What is expected of you and others at this level:

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope. Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

This role is 100% remote / work from home.

#REMOTE

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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