Overview
Mgr, Medical Writing at Syneos Health. 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 centers the customer and the patient in everything we do, and we collaborate across functional service provider partnerships or full-service environments to help customers achieve their goals.
We are a global team that values agility and a relentless focus on delivering therapies faster while changing lives. Work here matters everywhere.
Responsibilities
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 maintains 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%).
Qualifications
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 with excellent communication skills.
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.
About Syneos Health
Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs and commercial insights into outcomes to address modern market realities. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and 200+ studies across 73,000 sites and 675,000+ trial patients.
Our 29,000 employees across 110 countries know that work here matters everywhere. We are committed to developing our people through career development, engagement, and a Total Self culture that unites us globally.
No matter your role, you’ll take the initiative and challenge the status quo in a highly competitive and ever-changing environment. Learn more at our website.
Website:
http://www.syneoshealth.com
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its discretion. The Company will determine what constitutes equivalent qualifications. The Americans with Disabilities Act applies, including reasonable accommodations to assist employees or applicants in performing essential functions.
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