Senior Medical Writer

4 weeks ago

Montréal QC, Canada Syneos Health Full time €55,800 - €108,600

Senior Medical Editor
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance.
• Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed.
• Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk.
• Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles.
• Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable.
• Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process.
• Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices.
• Performs data integrity review of assigned documents to ensure accuracy.
• Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work.
• Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget.
• May compile and publish medical writing deliverables.
Bachelor’s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience.
• Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills.
• Ability to work independently as well as part of a team and keep others informed of the progress and status of projects.
• Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred.
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.
We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Further, nothing contained herein should be construed to create an employment contract. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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