Medical Writer (Contractor)

Accountabilities:

• Analyze and interpret safety data: Review clinical and non-clinical safety data, alongside relevant scientific sources, to support accurate, evidence-based pharmacovigilance documentation and regulatory submissions.

• Prepare aggregate safety reports: Author and review periodic and development safety reports, including Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Canadian annual reports, safety update reports, and addenda to clinical overviews.

• Develop risk management documentation: Prepare and review Risk Management Plans (RMPs) and related documents to support the assessment, communication, and mitigation of potential product safety risks.

• Author clinical and regulatory documents: Develop and review Clinical Study Reports, clinical study protocols, labeling documents, and other materials supporting clinical development, regulatory submissions, and post-marketing product maintenance.

• Conduct signal detection and assessment: Perform qualitative and quantitative signal assessments to identify, evaluate, and communicate potential safety concerns associated with medicinal products.

• Conduct scientific literature reviews: Search, assess, and summarize relevant scientific publications, incorporating appropriate evidence into aggregate reports and other pharmacovigilance deliverables.

• Support safety reporting operations: Generate Periodic Safety Line Listings (PSLLs) from safety databases and maintain accurate process trackers, ensuring effective documentation management and reconciliation.

• Coordinate regulatory and safety communications: Collaborate with Regulatory Affairs and other stakeholders to support appropriate reporting of drug safety information to health authorities and the prescribing community.

• Respond to regulatory inquiries: Contribute to responses to regulatory agency questions and Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, providing clear, accurate, and scientifically supported information.

• Ensure quality and timely delivery: Verify that all client deliverables meet applicable regulatory requirements, internal quality standards, and agreed project timelines.

• Provide subject matter expertise: Serve as a medical writing and pharmacovigilance resource, offering guidance, training, and mentoring to colleagues and pharmacovigilance associates.

• Support evolving business needs: Contribute to high-priority ad hoc assignments, adapt to changing project requirements, and collaborate effectively with clinical research organizations (CROs), partner teams, and other stakeholders.

Requirements:

• Education: Bachelor's degree or equivalent qualification in life sciences, pharmaceutical sciences, medicine, or a related discipline.

• Medical writing experience: At least two years of professional medical writing experience, ideally within pharmaceutical development, clinical research, drug safety, or pharmacovigilance. Two to six years of experience is preferred.

• Regulatory writing expertise: Familiarity with authoring and reviewing aggregate safety reports, including PSURs, PBRERs, DSURs, PADERs, and annual safety reports, is highly desirable.

• Pharmacovigilance knowledge: Understanding of drug safety regulations, pharmacovigilance practices, safety surveillance, risk management, and applicable regulatory reporting requirements.

• Clinical documentation experience: Experience preparing or reviewing Risk Management Plans, Clinical Study Reports, clinical protocols, labeling documents, or related regulatory materials is an advantage.

• Safety data analysis: Ability to review and interpret clinical and non-clinical safety information, conduct literature searches, and contribute to signal detection and risk assessment activities.

• Regulatory interaction experience: Exposure to health authority inquiries, PRAC-related questions, or other regulatory communications is beneficial.

• Technical proficiency: Good computer skills and working knowledge of Microsoft Office applications, particularly Word, Excel, and Outlook.

• Communication skills: Excellent written, verbal, and presentation skills, with the ability to communicate complex scientific information accurately and clearly.

• Organizational abilities: Strong attention to detail, time management, and prioritization skills, with the ability to manage multiple assignments and meet deadlines.

• Collaboration and relationship management: Ability to build productive relationships, work across multidisciplinary teams, and communicate effectively with internal and external stakeholders.

• Adaptability and initiative: A proactive, resourceful, and collaborative approach, with the flexibility to respond to changing business priorities and urgent project requirements.

• Mentoring and knowledge sharing: Ability or willingness to provide subject matter guidance and support the training and development of colleagues.

• Schedule flexibility: Willingness to occasionally work extended or flexible hours when necessary to meet client requirements and critical project deadlines.

• Work arrangement: Ability to support remote contract assignments serving teams and clients within the scope of the engagement.

Benefits:

• Competitive hourly compensation based on medical writing and drug safety experience.

• Remote working arrangement.

• Flexible, as-needed contract engagement, with assignments and extensions defined through a Scope of Work consulting agreement.

• Opportunity to contribute to pharmaceutical product safety, clinical development, and regulatory compliance.

• Exposure to diverse pharmacovigilance activities, scientific documentation, and regulatory reporting requirements.

• Collaboration with experienced drug safety professionals, clinical research teams, and regulatory specialists.

• Opportunities to strengthen medical writing expertise and contribute subject matter knowledge across projects.