Job Description
Overview 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 patient, aiming to simplify and streamline work to better serve our clients and patients. Whether you join in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with problem solvers to accelerate the delivery of therapies and change lives.
WORK HERE MATTERS EVERYWHERE
Why Syneos Health We are passionate about developing our people through career development and progression; supportive line management; technical and therapeutic area training; peer recognition and total rewards program.
We are committed to our Total Self culture – authentic, global, and focused on taking care of our people.
We value diversity of thoughts, backgrounds, cultures, and perspectives to create a place where everyone belongs.
Job Responsibilities 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. Leads the resolution of comments from the client.
Completes a variety of documents that may include clinical study protocols and amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; plain language summaries; periodic safety update reports; clinical development plans; IND submissions; integrated summaries; NDA/eCTD submissions; journal manuscripts; abstracts, posters, and presentations for scientific meetings.
Adheres to regulatory standards (e.g., ICH E3), company SOPs, client standards, approved templates, authorship requirements, and style/formatting guides, delivering on time and on budget.
Coordinates quality and editorial reviews; ensures source documentation is managed appropriately; leads team document reviews as needed.
Acts as peer reviewer for internal teams to ensure scientific content, clarity, consistency, and proper format.
Reviews statistical analysis plans and table/figure/listing specifications for content, grammar, formatting, and consistency; provides feedback to define statistical output needs.
Interacts with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
Performs online clinical literature searches and complies with copyright requirements.
Identifies and proposes solutions to resolve issues; provides technical support, training, and consultation; may contribute to internal materials and process improvements.
Mentors and leads less experienced medical writers on complex projects as necessary; develops deep expertise on industry topics and regulatory guidelines.
Aware of budget specifications for assigned projects and communicates status and changes to medical writing leadership.
Completes required administrative tasks within specified timeframes; performs other duties as assigned; minimal travel may be required (less than 25%).
Qualifications 3–5 years of relevant experience in science, technical, or medical writing.
Experience in the biopharmaceutical, device, or contract research organization industry.
Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
Extensive knowledge of English grammar and ability to communicate clearly; familiarity with AMA Manual of Style.
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 conducted studies across thousands of sites and patients. We are dedicated to building a diverse, inclusive, and authentic workplace.
Equal Opportunity Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender, gender identity, sexual orientation, protected veteran status, or disability. If you require reasonable accommodation to complete any part of the application process, please contact us at: jobs@syneoshealth.com.
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Job Tags
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