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Senior Medical Writer

Position Summary:

  • The Senior Medical Writer (SMW) is responsible for writing, editing, and reviewing clinical and regulatory documents for drug development that include, but are not limited to, clinical study reports, investigator’s brochures (IBs), protocols, and integrated regulatory summary documents.


Essential Functions:

  • Writes and edits clinical and regulatory documents that effectively and clearly convey scientific data, and comply with regulatory guidelines in terms of content, structure, and style.
  • Communicates effectively with document clients, and manages document development and review processes to ensure timely completion.
  • Understands the key components and messages for regulatory submissions as embodied in FDA and ICH guidelines.
  • Stays current with therapeutic area(s) relevant to assigned projects.
  • Uses appropriate company stylistic conventions.
  • Stays up-to-date on the software used for this function.


Preferred Experience:

  • At least 5 years of industry experience as a regulatory medical writer.
  • Experience writing clinical documents such as IBs, clinical study reports (including narratives), protocols, sample informed consent forms, and annual reports.
  • Experience writing regulatory documents such as CTD summaries, regulatory meeting packages, safety updates, responses to regulatory authorities, and SOPs.


Preferred Education:

  • Bachelor’s degree in a scientific discipline.


Preferred Additional Skills:

  • Knowledge of, or aptitude for understanding, scientific and medical concepts; familiarity with the drug development process and regulatory documentation.
  • Demonstrated ability to write clear, concise, and effective drug development documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.
  • Good team player; excellent written and verbal communication skills, and the ability to work well with others including remotely.
  • Proven document planning and project management skills, including managing document review meetings.
  • Highly detail-oriented and self-motivated, with excellent follow-through.
  • Ability to meet timelines without compromising document quality.
  • Ability to ensure consistency within and across documents to avoid confusion.
  • Competency in relevant software applications.
  • Committed to the values of integrity, accountability, transparency, scientific rigor, and drive.
  • Current US work authorization required.
  • Ability to travel domestically as needed.
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