Senior Scientific Writer - Clinical Protocols & Regulatory

WELL Health Technologies Corp

Toronto

Remote

CAD 75,000 - 80,000

Full time

2 days ago

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Job summary

WELL Health Technologies Corp in Canada is seeking a Scientific Medical Writer 1 for a full-time, remote role (GTA). You will write Phase 1-4 study protocols, bioequivalence studies, and informed consent forms, and perform literature searches and regulatory discussions.

You will collaborate with PK scientists, biostatisticians, and regulatory agencies to ensure GCP compliance and timely study design. A PhD and 3+ years of protocol writing, plus CRO experience, are required, with excellent

Qualifications

PhD in Life Sciences required.
3+ years of scientific protocol writing experience.
CRO experience in Phase I and Bioequivalence is a plus.
Excellent scientific writing and communication skills.

Responsibilities

Write Phase 1-IV and Bioequivalence study protocols and Informed Consent Forms.
Perform literature searches, NDA review, and scientific discussions for BE and early phase design.
Review non-clinical data for transition to First in Human trials.
Interact with PK scientists and biostatisticians to align study design with regulatory standards.
Interact with Institutional Review Boards regarding protocols and consent documents.
Assist in developing SOPs and guidelines for the department.
Assist with regulatory agency preparations and participate in inspector discussions when needed.
Work with scientific and clinical teams to ensure documents meet GCP and SOP requirements.
Coordinate timelines with external departments to meet study milestones.
Perform other work within the Scientific Affairs department as needed.