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Clinical Trial Specialist jobs

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    • Medical Devices (Class I–II).
    • Natural Health Products (NHPs/NPNs).
    • The RAS plans, authors, files and maintains regulatory submissions and dossiers, and ensures…
    • Prepare and issue trial-specific reports and queries to clinical sites.
    • Submit requests for shipment of MRI supplies and trial-specific sFTP account creation.
    • To facilitate the implementation and management of the clinical trial.
    • Compile documentation for qualification of clinical sites.
    • Aptitude to learn and retain CTT CDD application rules and support procedures and broader related clinical trials processes to effectively troubleshoot and…
    • At least five years of experience in clinical trial data processing and management.
    • Aptitude to learn and retain CTT application rules and support procedures…
    • The Associate Director is responsible for working with the Clinical Operations team to deliver high-quality, client-centered, and profitable approaches to…
    • Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred).
    • Rendering the completed final Word report to PDF.
    • Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
    • Experience in Phase I through Phase IV clinical trials…
  • View similar jobs with this employer
    • Strong written and verbal communication skills, with experience in scientific communications or clinical program coordination.
    • Function as a technical and operational leader, serve as a Principal level Lead Data Manager for individual clinical trials or a program of clinical trials,…
    • Create and maintain clinical trial Data Management Study Binders.
    • Demonstrated an in-depth understanding of clinical trial data management concepts, processes…
    • Review and query clinical trial data according to the Data Management Plan.
    • May assist in building clinical databases.
    • Ability to undertake occasional travel.
    • Minimum of 3+ years of experience in clinical trial start-up, with demonstrated leadership experience.
    • The Start-Up Manager is responsible for overseeing and…
    • In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes.
    • Experience in safety monitoring, adverse event reporting,…
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    • Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials,…
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Job Post Details

Pharmaceutical Regulatory Affairs Specialist - job post

CRL Synergy
Calgary, AB T2S 1W3
$68,000–$100,000 a year - Full-time

Job details

Pay

  • $68,000–$100,000 a year

Job type

  • Full-time

Location

Calgary, AB T2S 1W3

Benefits

Pulled from the full job description

  • Paid time off
  • Vision care
  • Dental care
  • Life insurance
  • Disability insurance
  • On-site gym
  • Extended health care

Full job description

Job Overview
CRL Synergy, one of Canada’s largest and fastest-growing suppliers of control label products, is seeking a detail-oriented and proactive Regulatory Affairs (RAS) Specialist.CRL Synergy is seeking a Regulatory Affairs (RAS) Specialist who can thrive in a fast-paced environment that involves working in an office team environment.

The Regulatory Affairs Specialist is the site lead for all Health Canada submissions and post-market activities covering four product categories sold across Canada:

  • Drugs (DIN-assigned OTC)
  • Cosmetics
  • Medical Devices (Class I–II)
  • Natural Health Products (NHPs/NPNs)

The RAS plans, authors, files and maintains regulatory submissions and dossiers, and ensures compliant labelling/advertising.

This role will also provide quality assurance support through maintenance of the RA SOPs, ensuring they are current and implemented, perform data collection, and subsequent analysis.

The successful candidate will provide support for new product development, ensuring Health Canada and customer requirements are being met, including labelling accuracy for new and modified product.

Responsibilities

  • Oversight of Pharmacovigilance program

· Collaborate with cross-functional teams to implement corrective and preventive actions (CAPA) related to customer complaints.

· Participate in risk management activities and contribute to the development of risk assessment strategies.

  • Ensuring accurate record keeping and filing as per organizational procedures.
  • Handle clerical and administrative activities.
  • Review and assess customer complaints for adverse reactions and reportable incidents. Perform surveillance activities for ongoing product quality and safety.
  • Complete Annual Summary Reports and perform screening of scientific literature for product safety information.
  • Assisting in updating methods and procedures (SOPs) related to the Quality Management System with a focus on the customer complaint and pharmacovigilance program.

Qualifications

  • Bachelor’s degree in a relevant field; advanced degree preferred.
  • Proven experience in regulatory affairs or a related field, with a strong understanding of compliance requirements.
  • Demonstrated skills in project management, including the ability to manage multiple projects simultaneously.
  • Strong leadership abilities with experience in supervising teams or mentoring staff.
  • Excellent analytical skills with a focus on process improvement methodologies.
  • Familiarity with sales or business development processes is a plus.
  • Exceptional communication skills, both written and verbal, with the ability to effectively convey complex information to diverse audiences. Join us in making a difference through compliance excellence!

Job Type: Full-time

Pay: $68,000.00-$100,000.00 per year

Benefits:

  • Company events
  • Dental care
  • Disability insurance
  • Extended health care
  • Life insurance
  • On-site gym
  • On-site parking
  • Paid time off
  • Vision care

Education:

  • Bachelor's Degree (preferred)

Experience:

  • Regulatory Affairs: 2 years (preferred)

Work Location: In person

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