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Medical Writing jobs in Calgary, AB

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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…
    • Actively contribute to report writing and detailed economic analyses and modelling.
    • Our Total Rewards package includes a discretionary bonus program, a…
    • You are comfortable working with both qualitative and quantitative inputs, including conversations, interviews, survey data, partner insights, and performance…
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    • This position includes benefits of life insurance, medical/dental and short-term/long-term disability, RRSP contributions after one year of employment, and 15…
    • Ideal candidates have an established track record of news reporting, writing clearly and with style, and with a grasp of New York Times style guidelines.
    • C’est pourquoi les gens aiment travailler chez nous.
    • Les possibilités de changer les choses dans le cadre d’initiatives client intéressantes sont illimitées…
    • Experience with proposal writing and/or project management.
    • Depending on your employment status, AECOM benefits may include medical, dental, vision, life, AD&D,…
    • Conduct technical writing and regulatory research.
    • Excellent writing, communication, organization, attention to detail, and time management skills.
    • Excellent technical writing skills, with experience preparing complex reports and winning proposals, and mentoring junior team members.
    • Comprehensive health insurance – medical/dental/vision coverage.
    • Excellent verbal and written communication, including technical and scientific writing.
    • Assist in proposal writing as needed.
    • Exceptional benefits such as medical, dental, and vision insurance plans.
    • Assist with internal initiatives as needed.
    • Area: Gene Regulation in Stem Cell Biology, Brain Development, and Aging.
    • Duration: Initial appointment of 1 year, with renewal contingent on funding.
    • Experience in acute care/hospital-based medical research is an asset.
    • The Department of Medicine in the Cumming School of Medicine invites applications for a…
    • The Department of Medical Genetics in the Cumming School of Medicine invites applications for a Clinical Trial Assistant.
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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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