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Career Openings


Principal Medical Writer

ID: 674
Department: Medical Writing
Location: Cambridge Headquarters
# of Openings: 1

Description

Functional area:       

Medical Writing & Publications

 

Position description:

The Principal Medical Writer (PMW) will join an excellent and hard-working Medical Writing team. The PMW will independently develop clinical regulatory documents (eg, protocols, clinical study reports, NDA summary documents) for one or more marketed and/or investigational products. The PMW will represent Medical Writing on cross-functional teams and will develop timelines, drive document development, and serve as primary medical writing resource for those teams. In addition, the PMW may lead and/or support scientific publication projects – abstracts, posters, slide presentations, manuscripts – for one or more products. The PMW will report to the Senior Director of Medical Writing, will work closely with colleagues across R&D, and will be an exceptional team player.

 

Responsibilities:

  • Develop regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures
  • Ensure accuracy, consistency, and quality of all documents
  • Represent Medical Writing and provide medical writing expertise on cross-functional and cross-company teams
  • Develop detailed timelines for document development in line with team and company goals and procedures
  • Drive documents through multiple rounds of team review to final (ie, distribute documents for review, consolidate and resolve reviewer comments, run efficient roundtables, finalize for publication and signoff) in accordance with established timelines
  • Collaborate effectively across Ironwood and with Ironwood partner companies and external experts
  • Support medical writing colleagues as necessary (eg, document review, edit, and QC) and contribute to team excellence

 

Basic qualifications:

  • ≥ BA/BS and ≥ 10 years’ experience writing a broad range of clinical regulatory documents
  • Great collaborator with experience working on cross-functional teams
  • Strong communication, interpersonal, editorial, and organizational skills
  • Working knowledge of ICH guidelines, GCP, CTD, etc.
  • Proficiency in Microsoft Word (and familiarity with document template use), PowerPoint, and Excel
  • Ability to manage multiple documents and set clear plans and priorities
  • Poise under pressure
  • Exceptional attention to detail

 

Preferred qualifications:

  • Scientific background
  • Knowledge of GPP, ICMJE guidelines, and experience with scientific publications
  • Experience with clinical trial development


Ironwood is an Equal Opportunity 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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