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Medical Writing Consultant

L5

beacon hillSioux Falls, SDyesterday

Occupations

Writers and AuthorsRegulatory Affairs SpecialistsRegulatory Affairs Managers

Industries

Other Scientific and Technical Consulting ServicesAll Other Miscellaneous Ambulatory Health Care ServicesOffices of Physicians
Title: Medical Writer (Regulatory)
Location: REMOTE
Duration: 6 Months ongoingW2 or 1099 available35-40 hours a week
Position Summary: The scope of this position includes the independently writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigators Brochures, and clinical study reports. The person will lead cross-functional teams to write and development regulatory submission documents, regulatory response documents, and other IND/CTA or global regulatory submission documents using internal SOPs.
Key Responsibilities: Provides Medical Writing leadership for one or more clinical programs. Acts as a medical writing subject matter expert and works with cross-functional team to deliver on medical writing program goals. Authors and manages the completion of clinical documents and other assigned tasks within established timelines with the highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Drive document strategies and messages in a collaborative way with relevant project team subject matter experts.
Qualifications:
  • Master's or PhD in life or health science discipline in a relevant scientific field preferred.5-8+ years of industry experience as a Medical Writer.
  • Knowledge of clinical disclosure.
  • Oncology experience a preferred
  • Expert knowledge of standard clinical regulatory document types.
  • NDA experience with active contribution in planning and preparation of summary documents is required.
  • Excellent written communication skills, detailed oriented, self-directed and with the ability to be flexible and manage workload of multiple concurrent projects to meet project timelines.
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Apply now (opens in a new tab)

Level

SeniorL5

Location

Sioux Falls, SD

Occupation

Writers and Authors

Industry

Other Scientific and Technical Consulting Services

Posted

yesterday

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