Senior Medical Writer, Regulatory Strategic Writing

Lake County, Illinois, USA
Jun 24, 2018
Required Education
Bachelors Degree
Position Type
Full time
The Senior Medical Writer is responsible for providing regulatory document support to the regulatory, clinical, and other functional area teams, ensuring successful preparation of high-quality submission-ready documents and effective implementation of the regulatory writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions.

Key Responsibilities Include:

  • Serves as medical writing lead on regulatory documents (e.g., briefing packages, requests for information, responses to questions, orphan drug applications, breakthrough therapy designations, etc.). Works closely with Regulatory team(s) on document strategies. Implements all activities related to the preparation of necessary clinical or regulatory data into a comprehensive package for new and updated regulatory documents (US and ex-US).
  • Coordinates the review, approval, and other appropriate functions involved in the production of regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is obtained.
  • Converts relevant data and information into a form that meets regulatory document requirements. Explains data in manner consistent with the target audience(s) and/or regulatory requirements.
  • Effectively communicates regulatory document deliverables needed, the writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates and with an appropriate quality level. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
  • Understands, assimilates, and interprets sources of information with appropriate guidance/direction from development teams. Interprets and explains data generated from a variety of sources. Challenges conclusions when necessary.
  • Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
  • Knowledgeable of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to regulatory document projects. Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards.
  • Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned regulatory teams regarding computer-based technologies utilized by the respective departments (e.g., eDocs, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers and/or external vendor/agencies. Implements tactical process improvements.
  • Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science experience. Advanced degree preferable.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • 3 years of experience preparing clinical medical writing documents such as clinical study reports, protocols, investigator brochures, and/or relevant sections of the common technical document.
  • 3 years of relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • 3 years of experience in experimental design and clinical/preclinical data interpretation preferred.
  • Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
  • Working knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Experience in working with collaborative, cross-functional teams, including project management experience.
  • Ability to assimilate and interpret scientific content and translate information for appropriate audience.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Expert in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.

Equal Opportunity Employer Minorities/Women/Veterans/Disabled