Senior Medical Writer, Scientific Communications Job at Syneos Health, Inc. in K

Principal Medical WriterApply: Remote (Pre-Approved): USA-DE-Remote: Full time: Posted Today: 25113258Principal Medical WriterSyneos 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. technical and therapeutic area training; We are committed to building an inclusive culture - where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. 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**• Leads the clear and accurate completion of complex medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, defining document strategy and coordinating medical writingactivities within and across departments with minimal supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; plain language summaries; and abstracts, posters, and presentations for scientific meetings.• Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines, as well as company standard operating procedures, client standards, and company and/or client approved-templates, authorship requirements, and style and formatting guides, when completingmedical writing projects, on time and on budget.• Advises clients and study teams on data presentation and production strategies to ensure that client objectives/expectations are met and quality standards are maintained.• Leads team document reviews and reviews documents for technical issues. Coordinates quality and editorial reviews and ensures source documentation is managed appropriately.• Serves as expert peer reviewer for internal team, providing review comments to give maximum clarity of meaning, accuracy, and relevance, and to ensure that client objectives are met and overall quality standards are maintained.• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content,and for grammar, format, and consistency. Provides feedback to further define statistical output required and document needs.• Interacts and builds good working relationships with clients, department head, and team members in data management, biostatistics, regulatory affairs, and medical affairs, as necessary, to produce writing deliverables. Performs online clinical literature searches and complies with copyright requirements.• Serves as a key technical SME and contributes to development of internal materials and presentations on needed topics. Mentors and leads less experienced medical writers on complex documents.• Develops deep expertise on key topics in the industry and the regulatory requirements and guidelines that affect medical writing. Aware of budget specifications for assigned projects, communicating status and changes to medical writing leadership. Communicates status and changes to medical writing leadership; Represents the medical writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding writing projects.• Completes required administrative tasks within the specified timeframes.• Minimal travel may be required (less than 25%). Education* Advanced degree in a scientific discipline required (MS, PhD, PharmD, MD, or equivalent).* PhD or PharmD strongly preferred.Experience* Minimum 5 years of relevant experience within the pharmaceutical, biotechnology, medical communications, or consulting industries.* Demonstrated experience leading publication planning, publication strategy, and publication execution programs.* Proven track record developing and executing integrated publication plans across multiple studies and assets.* Strong hands-on scientific writing and content development experience, including manuscripts, congress abstracts, posters, and presentations.* We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.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.Further, nothing contained herein should be construed to create an employment contract. 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.Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients.
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