Overview
Principal Medical Writer at 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. Our Clinical Development model centers on the customer and the patient. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies to change lives.
Work here matters everywhere.
Responsibilities
* Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately
* Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
* Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
* Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
* Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
* Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
* Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
* Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
* Perform online clinical literature searches and comply with copyright requirements
* Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
* Mentor and lead less experienced medical writers on complex projects
* Develop deep expertise on key topics in the industry and regulatory requirements
* Work within budget specifications for assigned projects
Qualifications
* Bachelor’s degree in a relevant discipline with relevant writing experience; graduate degree preferred
* 3-5 years of relevant experience in science, technical, or medical writing
* Experience working in the biopharmaceutical, device, or contract research organization industry required
* Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required
* Experience writing relevant document types required
* Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style
Necessary Skills
* Strong presentation, proofreading, collaborative, and interpersonal skills
* Strong project and time management skills
* Strong proficiency in MS Office
* Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information
Additional information: The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and responsibilities. The Company will determine what constitutes as equivalent to the qualifications described above. The Company is committed to compliance with applicable laws and regulations, including reasonable accommodations under the Americans with Disabilities Act where appropriate.
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