[Hiring] Manager, Medical and Scientific Writing @Everest Clinical Research

Role Description

To drive continued success in this exciting clinical research field, we are seeking committed, skilled, and customer-focused individuals to join our winning team as Manager, Medical and Scientific Writing for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

• Provide a leadership role in the day-to-day operations of the medical and scientific writing functional area.
• Mentor the project team members for the responsible projects and monitor compliance and adherence to the established standards.
• Perform peer review for clinical and scientific documents developed by other Medical Writers.
• As a Lead Medical Writer, author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications.
• Recruit, train, motivate, and develop staff to assure high levels of performance with strong professional and technical expertise.
• Set and achieve annual departmental goals and objectives.
• Monitor performance metrics, Key Performance Indicators (KPIs), and perform analysis of the metrics for medical and scientific writing activities.
• Participate in the development and maintenance of standards for medical and scientific writing and document publishing.
• Interact with clients with a focus on client relationship management and quality deliverables.
• Assist with new business development, including generation of cost estimates and Requests for Proposal responses.
• Perform business analysis and benchmarking in the business area; find room for continuous improvement.
• Serve on the management team ensuring departmental needs and concerns are represented.
• Ensure compliance with, and keep current, on all applicable regulations for medical and scientific writing and on Everest Guidance Documents.

Qualifications

• Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least 11 years of experience in medical writing practice in a pharmaceutical clinical trial or scientific research environment.
• At least 2 years of experience in managing projects and/or people.
• Experience with medical writing for clinical research, including CSRs, other regulatory submission documents, and scientific publications.
• Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset.
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods.
• Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.
• Good organizational skills with the ability to adapt and adjust to changing priorities and to handle multiple projects and clients.
• Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports.
• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
• Comprehensive skills in MS Office applications and Adobe Acrobat.
• Computing skills with TRS Toolbox pharma edition plugin an asset.

Benefits

• Robust benefits package to support your health, well-being, and growth.
• Medical, dental, and vision coverage.
• Life & AD&D insurance.
• Short- and long-term disability.
• Tuition reimbursement.
• Fitness reimbursement.
• Employee assistance program (EAP).
• Pension plan.
• Generous paid time off and sick leave.
• Opportunity to earn a performance-based bonus.
• Estimated Salary Range: $130,000 - $150,000.