Current Postings

We regularly update this page with job opportunities, so please check back often. Our current postings are below:  

We are seeking a Clinical and Regulatory Specialist, Medical Writer to join our growing team at Applied Pharmaceutical Innovation (API). The Clinical and Regulatory Specialist, Medical Writer will be responsible for writing and overseeing the writing of various clinical and regulatory documents, including investigator brochures, clinical study reports, among others. Reporting to senior management, this person will ensure the documents are of high quality and completed in a timely fashion compliant with company goals and regulatory guidelines. The successful applicant will undertake the following roles and responsibilities:

Roles & Responsibilities

  • Write, edit, or collaborate on the development of clinical and regulatory documents (e.g. investigator brochures, clinical trial protocols, regulatory ethics submissions, INDs, pre-clinical and clinical summaries)
  • Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to, first draft authoring, pre-clinical and clinical data interpretation, reference retrieval, generating bibliographies, editing 
  • Interpret and formulate key messages from pre-clinical, clinical, and scientific data 
  • Perform literature-based research to support writing activities
  • Develop best practices for authoring and reviewing
  • Develop and maintain templates and outlines for key documents 
  • Manage execution of documents, including creating, maintaining, and communicating timelines
  • Participate in the development of timelines for regulatory documents and lead preparation of assigned deliverables

Qualifications

  • Graduate degree in a scientific or medical field; pharmaceutical sciences field considered an asset
  • Minimum 3 years’ experience as a medical writer in the CRO/pharmaceutical field/biotech industry
  • Experience in medical writing, editing, and clinical development; with an emphasis on various documents, including but not limited to, investigative brochures, CMC preparation, IND applications
  • Experience and a strong understanding of pharmaceutical drug development
  • Demonstrated ability to distill pre-clinical and clinical data 
  • Familiarity with regulatory filings for various regulatory bodies, including Health Canada, FDA, and/or European Medicines Agency 
  • Strong planning and project management skills 
  • Exceptional oral and written communication skills, with a dedication to quality and reliability
  • Ability to be productive with minimal supervision and minimal administrative support
  • Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design)

Contract Duration:  Full-time, ongoing

Interested applicants should input a cover letter and resume below. 

Due to the high volume of applications received, only successfully screened applicants will be contacted for an interview. The position will remain open until a suitable candidate is selected.  

We are seeking an experienced multidisciplined Quality Assurance Manager to manage and direct personnel and activities of Quality Assurance at the company, ensuring company and regulatory compliance relating to the production and distribution of parenteral and sterile finished dosage forms (FDFs) and active pharmaceutical ingredients (APIs). This encompasses compliance in facilities, equipment, personnel, production and lab operations having an impact on the identity, strength, quality and purity of product supplied by the company.

Product quality is assured by designing, implementing and monitoring a robust quality system, utilizing programs that include Quality Risk Management (QRM), internal and external audits, Annual Product Quality Review (APQR)/Assessments and Non-Conformance/Corrective and Preventive Actions (NC/CAPA).

This position reports directly to the company CEO and is responsible for all Quality decisions at the company, including final release for all FDFs and APIs. This position is also responsible for ensuring compliance across a diverse range of regulatory requirements at the company including – APIs, raw materials, biological products, vaccines, medical devices, cell cultures and Natural Health Products.

Responsibilities

Directing the Quality Assurance Department 

  • Review of batch manufacturing and packaging records and release of bulk and FDFs.
  • Design and implement a Standard Operation Procedures (SOP) system, incorporating protocols and validations.
  • Implement any market product recalls/withdrawals, as applicable, with the regulatory department. 
  • Sign off on all GMP related documentation.
  • Sign off on NC/CAPA and product complaints.

Directing Quality Compliance

  • Assess Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP) and Good Distribution Practices (GDP) compliance risk areas and develop and implement mitigation measures, as required.
  • Hosting and/or carrying out internal and external audits, including regulatory agency audits and customer audits, as applicable.
  • Ensuring compliance of the site with Health Canada current Good Manufacturing Practices (cGMP) for FDFs and APIs.

Regulatory Support

  • Provide Quality input and support for Drug Master File (DMF) submissions and maintenance of approvals.       
  • Provide Quality input and support for Abbreviated New Drug Submissions (ANDS) and maintenance of approvals.     
  • Provide Quality input into Annual Product Quality Review (APQR).         
  • Maintain Site Master File Site (SMF).                                                                 

Personnel Organizational Management

  • Accomplish quality assurance human resource objectives by recruiting, selecting, orienting, training, assigning, scheduling, coaching, counseling, as per company policy.
  • Performance planning, monitoring, appraising, and reviewing job contributions.
  • Enforcing policies and procedures.
  • Responsible for performance management of direct reports.                                                                                        

Validations/Qualifications 

  • Validate quality processes by establishing product specifications and quality attributes together with Engineering, Production and Quality Control; measuring production.
  • Determining operational and performance qualifications.
  • Writing and updating quality assurance procedures.

Improving Product Quality                                                                                                                                                          

  • Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits. 
  • Investigating customer complaints.
  • Collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
  • Update job knowledge by studying trends in and developments in quality management. 
  • Participating in professional organizations.

Data Recording and Integrity

  • Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends, including failed processes, stability studies, recalls, corrective actions, and re-validations.                                                                                                                                                                                     
  • Ensure computer systems are validated and in compliance.
  • Implement a Quality Management System (QMS).

Budgets and CAPEX

  • Maintain departmental expenses within an agreed budget.    
  • Review monthly operating costs and output for department.             
  • Ensure CAPEX is within approved budget and on time.

Safety of Personnel

  • Ensure compliance with workplace policies and procedures for risk identification, risk assessment and risk control – Hazard Analysis and Critical Control Points (HACCP).
  • Department to identify and report on health and safety risks, accidents, incidents, injuries and property damage at the workplace.
  • Department to participate in established committees/teams relating to health, safety and environmental control.

Requirements

Knowledge and Experience – Required

  • Must hold a Canadian university degree or a degree recognized as equivalent by a Canadian university or Canadian accreditation body related to pharmaceutical product manufacture.
  • Training in GMPs, Management Supervisory Skills – Strong leadership skills.
  • GMP regulatory standards applicable to Canada, and a working knowledge of external regulations and requirements, such as US 21 CFR part 211 and EU GMP guide Part I.
  • 10+ years of experience in GMP manufacturing, Quality Assurance/Control/Compliance or similar operational areas in pharma production with: 
    • At least 4 years of senior management experience required in the manufacture and packaging of parenteral and sterile pharmaceutical products.
    • At least 4 years of senior management experience required in the manufacture and packaging of oral pharmaceutical products.                                                                                                                                                                       

Knowledge and Experience – Desirable

  • At least 2 years of senior management experience required in the manufacture and packaging of active pharmaceutical ingredients. 
  • Implementation of Laboratory Information Management System (LIMS)
  • Experience in finance, computerization and human resources.
  • CDMO experience preferred.
  • MRNA, vaccine experience, or complex parenteral development experience.
  • R&D experience.

Interested applicants should input a cover letter and resume below. The position will remain open until a suitable candidate is selected.

Become an API Team Member

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Please fill in the form below, and attach a cover letter and CV. Please note that applications without a cover letter will not be considered.

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