Mgr, Medical Writing

Updated: Yesterday
Location: USA-NC-Remote
Job :

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.

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? 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.

• 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, including FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
• Effective presentation, interpersonal, and leadership skills with a team-oriented approach.
• Strong Microsoft Office Suite skills.

Salary Range: $95,000.00 - $

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.

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