Mgr, Medical Writing

Mgr, Medical Writing role at Syneos Health. Description: 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. 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. Work here matters everywhere.

• Project-specific management responsibilities for medical writing staff members. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
• Reviews and edits departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products.
• Ensures adherence to Sponsor objectives and that quality standards are maintained.
• Supports the company's MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates.
• Assists with the preparation of budgets and timelines for medical writing activities (full-service clinical development projects and stand-alone medical writing projects) as needed.
• Assists with budgeting, revenue, invoicing, and forecasting as requested.
• Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics.
• Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings.
• Builds and maintain relationships with internal and external customers.
• Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise.
• Reviews performance of medical writing personnel (direct reports).
• Develops and maintains departmental SOPs and templates and acts as resource for implementation.
• Participates in the planning, writing, and assembly of medical writing deliverables, as needed.
• Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

• Bachelor's degree required with relevant scientific and/or medical knowledge and expertise.
• Experience in medical writing with progressive management experience and experience in a contract research organization or pharmaceutical/medical device company.
• Management experience preferred.
• Extensive knowledge of English grammar required, FDA and ICH regulations and guidelines.
• Knowledge of principles of clinical research and ISO standards; excellent communication skills.
• Effective presentation, interpersonal, and leadership skills with a team-oriented approach.
• Strong Microsoft Office Suite skills.

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. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion and with no prior notice. Equivalent experience, skills, and/or education will be considered. Nothing herein should be construed to create an employment contract. This description is intended to comply with applicable laws and regulations including the Americans with Disabilities Act, including reasonable accommodations when appropriate.