NCBiotech is hiring: Mgr, Medical Writing in Raleigh

Overview Description Mgr, Medical Writing 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. We aim to simplify and streamline work to make Syneos Health easier to work with. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate to change lives. Discover what our 29,000 employees across 110 countries already know: WORK HERE MATTERS EVERYWHERE . Why Syneos Health 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 — authentic self at work; we are dedicated to taking care of our people. We value diversity of thoughts, backgrounds, cultures, and perspectives to create a sense of belonging. Job 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 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 tracking and reviewing project metrics. Supports business development by assisting with proposal and costing development, bid defenses, and customer meetings. Builds and maintains relationships with internal and external customers; forms, maintains and leads productive cross-functional teams. Reviews performance of medical writing personnel (direct reports). Develops and maintains departmental SOPs and templates and acts as a resource for implementation. Participates in planning, writing, and assembly of medical writing deliverables, as needed. Performs senior reviews of medical writing deliverables, including reviews of statistical analysis plans and tables/figures/listings. 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; knowledge of FDA and ICH regulations and guidelines. Knowledge of principles of clinical research; excellent communication skills. Knowledge of 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. At Syneos Health, we provide an environment and culture in which our people can thrive, develop and advance. Benefits may include a company car or car allowance, health benefits (Medical, Dental, Vision), 401k with company match, eligibility for Employee Stock Purchase Plan, eligibility to earn commissions/bonus, and flexible PTO and sick time. Paid sick time eligibility varies by location. Syneos complies with applicable paid sick time requirements. Salary Range: 95,000.00 - 175,700.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients. No matter your role, you’ll take initiative and challenge the status quo in a dynamic environment. Learn more about Syneos Health at http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities listed are not exhaustive. The company may assign other tasks at its sole discretion. Equivalent experience, skills, and/or education may be considered. The company will determine what constitutes equivalence. Nothing herein should be construed as a contract. This description complies with applicable laws, including the EU Equality Directive and ADA accommodations where appropriate. #J-18808-Ljbffr