Job Title: Senior Medical Writer
Job Location: India - Asia Pacific - Home-Based
Company Overview
Syneos Health is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. The company combines clinical, medical affairs, and commercial insights to drive outcomes for modern market realities. Syneos Health is dedicated to making a meaningful impact on patients' lives and fostering a collaborative, diverse, and inclusive work environment.
Role Summary
As a Senior Medical Writer, you will lead complex writing projects, mentor less experienced writers, and develop a wide range of regulatory and clinical documents. This role requires strong leadership, organizational skills, and an in-depth understanding of clinical research, regulatory requirements, and industry practices. You will interact with various departments and provide high-quality medical writing for clinical trials, submissions, and presentations.
Key Responsibilities
Lead and manage medical writing projects, coordinating activities across multiple departments.
Develop a variety of documents, including clinical study protocols, clinical study reports, IND submissions, NDA and eCTD submissions, and clinical manuscripts.
Review statistical analysis plans and other relevant documents for content, grammar, format, and consistency.
Serve as a peer reviewer and mentor to junior medical writers.
Adhere to regulatory standards (e.g., ICH-E3) and company SOPs, ensuring timely delivery within budget.
Conduct clinical literature searches and stay up to date with industry practices and regulatory guidelines.
Maintain awareness of budget specifications for assigned projects.
Perform other administrative tasks as required and manage less than 25% travel.
Qualifications
Required
Education: Bachelor of Science or Arts (preferably in Social Sciences, English, Communications) with relevant scientific and/or medical knowledge.
Experience: Demonstrated experience in medical writing, with high proficiency in writing, proofreading, and leadership skills.
Skills:
Extensive knowledge of English grammar, FDA, and ICH regulations.
Familiarity with AMA style guide.
Proficient in Word, Excel, PowerPoint, email, and Internet.
Ability to interpret clinical data and communicate complex information effectively.
Desirable
Strong leadership, interpersonal, and presentation skills.
Previous experience in clinical research and regulatory environments.
Work Environment
Syneos Health fosters a Total Self culture, allowing employees to bring their authentic selves to work. The company offers career development, peer recognition, and a rewards program, focusing on creating a place where everyone feels they belong.
How to Apply
Candidates can apply directly through the Syneos Health career portal. The position is open to applicants globally, with flexibility for home-based work.
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