Manager, Medical and Scientific Writing

Everest Clinical Research (“Everest”) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence. Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s Corporate headquarters are located in Ontario, Canada and US headquarters in New Jersey, USA, with additional physical offices in Asia and Europe.

Everest is known in the industry for its high-quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s Everest.

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. This leadership role will involve hands-on planning, leading, performing, tracking, and delivery of assigned projects, to ensure goals and objectives are met, policies and procedures are being followed, and service is provided effectively and efficiently.
• 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, applying therapeutic area experience and scientific knowledge in the review.
• As a Lead Medical Writer, author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, etc., and clinical trial activities. These include but are not limited to briefing packages, regulatory Investigational New Drug (IND)/New Drug Application (NDA)/Biologics License Application (BLA) summaries and overviews, Integrated Summaries of Safety (ISS) and Efficacy (ISE), clinical study protocols, Clinical Study Reports (CSRs;
  
  full, abbreviated, or synoptic), Development Safety Update Reports (DSURs), Investigator’s Brochures, patient narratives, manuscripts, posters, and abstracts. Ensure that appropriate QC checks have been performed on the medical writing deliverables.
• Recruit, train, motivate, and develop staff to assure high levels of performance with strong professional and technical expertise. Complete annual and semi-annual performance reviews. Plan, implement, and oversee staff training and development process.
• 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 through participation in the development of related Policies, Standard Operating Procedures (SOPs), Working Instructions, guidelines, and good working practices.
• Participate in and contribute to the departmental efforts in investigating, establishing, and implementing new and advanced reporting systems, tools, and reports to improve the effectiveness of the medical and scientific…