Medical Writers

Sr Regulatory Medical Writer - CSR - Remote Home Based
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. 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 accelerate the delivery of therapies, because we are passionate to change lives.
We are passionate about developing our people, through career development and progression; technical and therapeutic area training; peer recognition and total rewards program.
We are continuously building the company we all want to work for and our customers want to work with. 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.
Leads the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. 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 completing medical writing projects, on time and on budget.
Coordinates quality and editorial reviews. Leads team document reviews, and reviews documents as needed.
Acts as peer reviewer for internal team to ensure document scientific content, clarity, overall consistency, and proper format.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts and builds good working relations with clients, department head, and peers 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.
Provides technical support, training, and consultation to department and other company staff. Mentors and leads less experienced medical writers on complex projects, as necessary.
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, working within the budgeted hours and communicating status and changes to medical writing leadership.
Minimal travel may be required (less than 25%).
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.
Roles within the Medical Writing job family are responsible for writing and editing manuscripts and other medical communications on clinical studies and/or scientific reports including special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication such as screening, analyzing, and summarizing additional data from other sources as needed. Prepares literature for new products and revises existing medical communication. Supports engagement and interaction with regulatory agencies through preparation of briefing books and response documents to health authority questions. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. May be responsible for entire projects or processes within area of responsibility.