Overview

EPM Scientific Senior/Principal, Medical Writer (Remote) Full Time in Montréal-Ouest, QC

EPM Scientific

Branch Montréal-Ouest QC CA

Position:
Senior/Principal, Medical Writer (Remote)
Location:
Montréal-Ouest, QC

Be the key decision maker in resolving critical issues that may have a financial impact. NDA/IND Submissions | Medical Writing*….

Senior/Principal, Medical Writer needed for Top Clinical Research Organization!

  • NDA/IND Submissions | Medical Writing

Location: Montreal OR Remote

Salary: $100,000-130,000 + bonus + excellent benefits

The Senior 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 clinical study reports, study protocols, investigator’s brochures, and manuscripts.

Key Responsibilities Include:

  • Conduct overall planning of the clinical sections of global submissions.
  • Work with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy.
  • Advise management regarding project resource requirements, and manage project-related activities of resources assigned.
  • Review statistical analysis plans and case report forms, as required.
  • Perform quality control (QC) review of clinical study reports and other submissions written by other medical writers.
  • Keep management informed on progress 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.

The Ideal Candidate Will:

Internally:

  • Be the key decision maker in resolving critical issues that may have a financial impact
  • Ability to manage a fast moving environment
  • Ability to communicate with cross functional teams and operations staff

PROFESSIONAL SKILLS & EXPERIENCE

  • BS/BSc/BA in a science or industry-related discipline.
  • 5 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.
  • Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred.

Job Type: Full-time

Salary: $130,000.00 /year

or proceed with Standard Application Form.

Employment Type: Full Time
Location: Montreal-West, QC, CA
Posted on: 2017-04-02
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