Manager, Medical and Scientific Writing

Everest Clinical Research Corporation; Markham; Hybrid; CAD 130,000 - 150,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Tuition Reimbursement

Fitness Reimbursement

Employee Assistance Program (EAP)

Pension Plan

Paid Time Off

Bonus

Job summary

Everest Clinical Research seeks a Manager, Medical and Scientific Writing to lead the day-to-day operations of the medical writing function at our Toronto/Markham, Canada location or remotely from a home-based office across Canada under our Work from Home policy.

You will oversee project delivery, mentor staff, perform peer reviews, and author regulatory documents (IND/NDA/BLA, CSRs, development documents) ensuring quality and regulatory compliance.

Qualifications

• Advanced degree in clinical or life sciences with substantial subject matter experience.
• 11+ years in medical writing within pharma/clinical trials.
• Experience managing projects and/or people (2+ years).

Responsibilities

• Lead day-to-day operations of the medical and scientific writing function.
• Mentor project team members and ensure adherence to standards.
• Perform peer reviews of documents for regulatory submissions and publications.
• Author regulatory documents (IND/NDA/BLA), CSRs, protocols, and reports.
• Develop staff, plan training, and set departmental goals.
• Interact with clients to manage relationships and support business development.

Skills

Medical writing

Leadership

Project management

Communication

Regulatory writing

GCP/ICH knowledge

Education

Ph.D. in Clinical/Life Sciences

Master's degree

Tools

MS Office

Adobe Acrobat

TRS Toolbox pharma edition

Job description

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.

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.

Accountabilities:

• 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 writing service offerings.
• 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.
• Plan and carry out professional development.
• Ensure compliance with, and keep current, on all applicable regulations for medical and scientific writing and on Everest Guidance Documents.

Requirements:

• 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 and 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 & Compensation:

We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and vision coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus.

Estimated Salary Range: $130,000 - $150,000.

To find out more about Everest Clinical Research and to review other opportunities, please visit our website at www.everestclinical.com .

We thank all interested applicants, however, only those selected for an interview will be contacted.

Everest is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will provide accommodations for candidates participating in any part of our recruitment and selection process.