Manager, Medical and Scientific Writing

Job summary

The Manager will lead the medical and scientific writing functional area by planning, performing, and delivering high-quality regulatory documents while mentoring project team members. They are also responsible for recruiting and developing staff, managing client relationships, and contributing to business development and departmental process improvements.

Job details

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: 1. 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. 2. Mentor the project team members for the responsible projects and monitor compliance and adherence to the established standards. 3. Perform peer review for clinical and scientific documents developed by other Medical Writers, applying therapeutic area experience and scientific knowledge in the review. 4. 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. 5. 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. 6. Set and achieve annual departmental goals and objectives. 7. Monitor performance metrics, Key Performance Indicators (KPIs), and perform analysis of the metrics for medical and scientific writing activities. 8. 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. 9. 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. 10. Interact with clients with a focus on client relationship management and quality deliverables. 11. Assist with new business development, including generation of cost estimates and Requests for Proposal responses. 12. Perform business analysis and benchmarking in the business area; find room for continuous improvement. 13. Serve on the management team ensuring departmental needs and concerns are represented. 14. Plan and carry out professional development. 15. Ensure compliance with, and keep current, on all applicable regulations for medical and scientific writing and on Everest Guidance Documents. Requirements: 1. Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter. 2. 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. 3. Experience with medical writing for clinical research, including CSRs, other regulatory submission documents, and scientific publications. 4. Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset. 5. Excellent understanding of clinical trials and common clinical trial statistical analysis methods. 6. Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing. 7. Good organizational skills with the ability to adapt and adjust to changing priorities and to handle multiple projects and clients. 8. Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports. 9. Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused. 10. 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 [http://www.ecrscorp.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. #LI-Remote #LI-KD1

What you’ll do

The Manager will lead the medical and scientific writing functional area by planning, performing, and delivering high-quality regulatory documents while mentoring project team members. They are also responsible for recruiting and developing staff, managing client relationships, and contributing to business development and departmental process improvements.

Requirements

Candidates must hold an advanced degree, preferably a Ph.D., in a life sciences field along with at least 11 years of medical writing experience in a clinical research environment. Additionally, at least 2 years of experience in project or people management and a strong understanding of GCP/ICH guidelines are required.

Benefits

• Medical coverage • Dental coverage • Vision coverage • Life insurance • AD&D insurance • Short-term disability • Long-term disability • Tuition reimbursement • Fitness reimbursement • Employee assistance program • Pension plan • Paid time off • Sick leave • Performance based bonus

Listed skills

• MS-Office · Preferred
• Project management · Preferred
• Client Relationship Management · Preferred
• Business development · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Medical writing
• Scientific writing
• Clinical research
• Regulatory submissions
• Project management
• People management
• Clinical study reports
• GCP/ICH guidelines
• Peer review
• Staff training
• Performance management
• Client relationship management
• Business development
• Statistical analysis methods
• MS Office
• Adobe Acrobat
• Statistical Analysis
• Business Metrics
• Organizational Skills
• Time Off Management
• General Scientific Knowledge
• Service Offerings
• Medical Devices
• Planning
• Research
• Peer Review
• Benchmarking
• Biotechnology
• Biopharmaceuticals
• Biologics License Applications (BLA)
• Brochures
• Customer Relationship Management
• Business Analysis
• Management
• Customer Service
• Clinical Research
• Clinical Trials
• Clinical Study Reports
• Communication
• Continuous Improvement Process
• Training And Development
• Data Management
• Employee Assistance Programs
• Standard Operating Procedure
• Leadership
• Marketing
• Key Performance Indicators (KPIs)
• Life Sciences
• Project Management
• Medical Writing

Job areas

• Science & Research
• Management & Leadership
• Healthcare
• Scientific Writer
• Medical Writer
• Authors and Related Writers
• Technical Writers