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Principal Medical Writer

Full-Time
at
Company Location:
Southborough
,
US
Job Location:
Remote
Southborough
,
US
Level:
Senior
Pay:
$
0.00
(
)
Category:
Medical
Posted on:
September 14, 2022
Might be expired
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Job Description

The Principal Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data.

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.

We do things differently than large CROs and would love to have you join our Veristat team!

The Principal Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, clinical study reports, study protocols, investigator’s brochures, aggregate safety reports, and manuscripts.

As a Principal Medical Writer You Will...

  • Conduct overall planning and writing of the clinical sections of global marketing applications and other regulatory documents.
  • Develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy.
  • Review statistical analysis plans as required.
  • Perform “peer” review of documents written by other medical writers as required.
  • Mentor junior members of the Medical Writing department.
  • Keep management informed on progress of documents and other project-related information.
  • Assist management in projecting resources and perform administrative duties as requested.
  • Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.

Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.

Experience + Requirements

  • Bachelor’s Degree in a science or related field.
  • Minimum of 8 to 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis.
  • Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required.
  • Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred.
  • Excellent regulatory writing skills (e.g., English usage) and a keen attention to detail also are required.

#LI-Remote
Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.

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