Project manager - Medical Writing

Project manager - Medical Writing Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. 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 deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 future colleagues already know: 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. • We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. Job Responsibilities For one of our single-sponsor partnerships we are currently looking to add a project manager medical writing to the team. Supervises staff and oversees development of direct reports by setting goals, conducting performance reviews, evaluating and monitoring training needs, creating development plans, mentoring, and coaching. Sets priorities, schedules department resources, implements company objectives, and creates alternative solutions to address business and operational goals. Recommends courses of action on salary administration, interviewing and selection, onboarding, 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. Manages and oversees their team’s medical writing deliverables per company or client standard operating procedures. Forms, maintains, and leads productive cross-functional writing teams, proactively addressing issues that arise. Reviews medical writing work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products. Performs reviews of statistical analysis plans and table/figure/listings. Supports the company’s medical writing leadership team in the planning, development, and implementation of document development strategies, the development and presentation of quarterly business updates, and resolution of issues. Assists with the preparation of budgets and timelines for medical writing activities as needed. Assists with revenue, invoicing, and forecasting as requested. Participates in the planning, writing, and assembly of medical writing deliverables, as needed. Develops and maintains departmental standard operating procedures and templates and acts as resource for implementation. Builds and maintains relationships with internal and external customers. Assists in tracking, maintaining, and reviewing department metrics. Supports business development activities by assisting with proposal and costing development, as well as bid defenses and customer meetings. Performs other work-related duties as assigned. Minimal travel may be required We are looking for a new colleague with the following: Bachelor’s degree required with relevant scientific and/or medical knowledge and expertise. At least 6 years of progressive experience in medical writing; plus 1 year of management/supervisor experience preferred. Management experience preferred in medical writing with experience in a contract research organization or pharmaceutical/medical device company. Excellent knowledge of English grammar; FDA, EU, ICH, and ISO regulations and guidelines governing drug/device and document development; and medical writing processes, systems, procedures, and best practices. Familiar with the principles of clinical research. Track record of successful relationship building with internal and external customers, including an ability to lead others and build teams. Ability to supervise and train employees and to organize, prioritize, and schedule work assignments. Strong management and independent work skills; written composition and editorial skills; and program planning and implementation skills. Strong communication, presentation, and interpersonal skills, with an ability to inform, influence, convince, and persuade. Strong Microsoft Office Suite skills. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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. Get to know Syneos Health 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. Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. 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.