Medical Writer

Regeneron Pharmaceuticals
2dOnsite

About The Position

The Medical Writer (MW) works with team members to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to resolve issues and escalate problems, as necessary. As a Medical Writer, a typical day may include: Works with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. The MW may serve as lead for a compound and is expected to manage and facilitate completion of documents Ensures adherence to internal standards and procedures Maintains document standardization via model documents/templates and appropriate peer review Remains current with writing guidelines and industry standards, participates in educational opportunities, reads professional publications This role may be right for you if you can: Drives document development meetings Articulates document strategy and timelines Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area Remains compliant with internal training

Requirements

  • Bachelor's degree (advanced degree preferred)
  • 1yr of relevant experience
  • Awareness of the clinical research process and regulations/guidelines
  • Scientific and technical reading, writing, and editing skillset
  • Organizational, interpersonal and communication skills
  • Working knowledge of MS WORD, Adobe Acrobat, PowerPoint, and familiarity with electronic document management systems

Responsibilities

  • Works with team members and with MW lead oversight to create the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas
  • Manage and facilitate completion of documents
  • Ensures adherence to internal standards and procedures
  • Maintains document standardization via model documents/templates and appropriate peer review
  • Remains current with writing guidelines and industry standards, participates in educational opportunities, reads professional publications
  • Drives document development meetings
  • Articulates document strategy and timelines
  • Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss
  • Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly
  • Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area
  • Remains compliant with internal training

Benefits

  • We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels!
  • For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.
  • For other countries’ specific benefits, please speak to your recruiter.

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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Number of Employees

5,001-10,000 employees

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