Job Title:
Senior Medical Writer
Company:
Syneos Health
Syneos Health® is a leading integrated biopharmaceutical solutions organization. They focus on accelerating customer success by translating clinical, medical affairs, and commercial insights into outcomes that address modern market realities.
Location:
India (Home-Based)
Job ID:
24003298-IND975
Job Description / Responsibilities:
Mentor and lead less experienced medical writers on complex projects.
Act as the lead for assigned writing projects.
Manage medical writing activities, coordinating within and across departments with minimal supervision.
Develop or support the creation of various documents, including but not limited to:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Clinical development plans
IND submissions and annual reports
Integrated summary reports
NDA and (e)CTD submissions
Investigator brochures
Clinical journal manuscripts, abstracts, and client presentations
Identify and propose solutions to issues that arise during the writing process.
Review statistical analysis plans, tables, figures, and listing specifications for accuracy.
Collaborate with departments such as data management, biostatistics, regulatory affairs, and medical affairs.
Serve as a peer reviewer for internal review teams.
Adhere to regulatory standards like ICH-E3 guidelines, SOPs, and client-approved templates.
Perform online clinical literature searches.
Maintain familiarity with current industry practices and regulatory guidelines.
Ensure that projects are completed within budget and time constraints.
Perform other related tasks as needed.
Qualifications:
Education: Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, Communications preferred) with relevant scientific/medical knowledge.
Extensive knowledge of English grammar, FDA and ICH regulations, and familiarity with the AMA style guide.
High degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
Proficiency in Word, Excel, PowerPoint, email, and internet tools.
Ability to interpret and present clinical data and other complex information.
What Syneos Health Offers:
A dynamic and innovative work environment.
Opportunities for career development and progression.
A culture dedicated to inclusion, diversity, and belonging.
Additional Information:
Syneos Health is committed to providing reasonable accommodations for individuals with disabilities and ensuring compliance with relevant laws, including the Americans with Disabilities Act. The company may assign other tasks or duties as necessary and evaluates candidates based on equivalent experience, skills, or education.
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