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Quebec city medical writer jobs trial#
Quebec city medical writer jobs professional#

Quebec city medical writer jobs professional#

That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.Our success depends on the knowledge, capabilities and quality of our people. Why ICON?Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

Experience in electronic publishing format preferred.

Excellent time management skills and a proven ability to work on multiple projectsat any given time.

Ability to work autonomously, as well as in a team.

Ability to prioritize and multi-task successfully in a fast-paced environment.

Excellent written and verbal communication skills.

Ability to work precisely according to procedures and regulations.Ability to approach issues from various perspectives and accurately summarize datato draw a conclusion.Ability to proofread documents for compliance with internal and external guidancedocuments.Ability to understand FDA/international regulations, ICH guidelines, and applicableUS/international regulatory processes related to document preparation andproduction (including CTDs).

Basic understanding of drug development, including the phases, processes, andtechniques used within a clinical development environment from protocol designthrough regulatory submission.eCTD development, publishing, and submission experience preferred.Knowledge of all FDA and ICH guidelines for clinical reporting required.Minimum of 5-7 years of pharmaceutical/biotechnology-related medical writingexperience required.Ensure proper development and coaching of junior writersīachelor’s degree in a scientific, medical or clinical discipline or related fieldrequired, PhD preferred.

Quebec city medical writer jobs trial#

Collaborate with members of clinical trial teams and other functions within medicalwriting to ensure project deadlines are met by providing content developmentsupport, research, and editing functions for each program.Partner with Quality Assurance (QA) during an audit of clinical trial documents toensure timely response to findings.Ensures all clinical documents are standardized according to the client style guideand are based on company-approved document templates to ensure quality andconsistency of the portfolio.Draft and manage documents that are well-organized, accurate, consistent, andcomply with applicable company SOPs and regulations.Support the clinical medical writing team, in developing content for a variety ofclinical regulatory documents, including clinical protocols, informed consents (ICFs),clinical study reports (CSRs), investigator brochures (IBs), safety narratives, andeCTD modules.The position will have the following key responsibilities: As a Principal Medical Writer you will be responsible For the expansion of our team, argenx is looking for a Medical Writer, who will beresponsible for providing medical writing support for the development of complex clinicaldocuments for regulatory submissions including, but not limited to clinical protocols,informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patientnarratives, annual reports, and other key clinical and regulatory documents.This individual will support the overall strategy for all medical writing processes accordingto client standards.