Job Title:
Medical Writer II (Clinical Trial Transparency)
Company:
Syneos Health
Location:
India-Asia Pacific - Home-Based, India
Job ID:
25002559
Job Type:
Full-Time
Role Overview:
The Medical Writer II will compile, write, and edit medical writing deliverables with minimal supervision. This includes creating documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and annual reports. The role involves mentoring less experienced medical writers, interacting with cross-functional departments, and ensuring adherence to regulatory standards and client requirements.
Key Responsibilities:
Medical Writing & Editing:
Compile, write, and edit medical writing deliverables (clinical study protocols, clinical study reports, patient narratives, etc.) with minimal supervision.
Review statistical analysis plans and table/figure/listing specifications for consistency and correctness.
Mentorship & Peer Review:
Mentor less experienced medical writers on projects.
Serve as a peer reviewer, addressing team comments to ensure clarity, scientific accuracy, and consistency.
Collaboration & Communication:
Interact with teams in data management, biostatistics, regulatory affairs, and medical affairs to produce high-quality writing deliverables.
Communicate effectively with internal and external stakeholders to meet client expectations.
Regulatory Compliance:
Adhere to regulatory standards, including ICH-E3 guidelines and company-specific standard operating procedures and templates.
Conduct clinical literature searches and apply findings appropriately.
Professional Development:
Stay updated on regulatory guidance and client expectations impacting medical writing.
Contribute to personal and team growth through continuous professional development.
Project Management:
Manage budget specifications for assigned projects, ensuring work is completed within budgeted hours.
Complete administrative tasks on time and manage project timelines effectively.
Requirements:
Education:
Bachelor of Science or Bachelor of Arts (preferably in Social Sciences, English, Communications, or a related field) with relevant scientific or medical knowledge and writing expertise.
Experience:
Extensive knowledge of English grammar and familiarity with FDA and ICH regulations and AMA style guide.
Proven independence in medical writing, with effective presentation, proofreading, and leadership skills.
Skills:
Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
Familiarity with clinical research principles and the ability to interpret and present clinical data.
Why Syneos Health?
Syneos Health values career development and progression, offering supportive management and technical training.
The company emphasizes diversity and inclusion, fostering a culture where employees can authentically be themselves.
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