Medical Writer II
Overview
The Medical Writer II position at Syneos Health offers an exciting opportunity to contribute to critical medical writing projects within a globally respected biopharmaceutical solutions organization. This role involves crafting, editing, and delivering high-quality regulatory and clinical documentation while mentoring junior writers and collaborating with cross-functional teams.
Key Responsibilities
Mentorship and Collaboration:
Guide and mentor less experienced medical writers on various projects.
Collaborate with internal departments, including data management, biostatistics, regulatory affairs, and medical affairs, to deliver comprehensive medical writing outputs.
Document Development:
Compile, write, and edit a wide range of documents such as clinical study protocols, amendments, reports, patient narratives, annual reports, and investigator brochures.
Adhere to regulatory standards (e.g., ICH-E3 guidelines) and client-specific templates for deliverables.
Quality Assurance:
Peer-review documents to ensure scientific accuracy, consistency, and proper formatting.
Review statistical analysis plans and related documentation for clarity and compliance.
Regulatory Compliance:
Conduct online clinical literature searches to ensure content accuracy.
Maintain awareness of regulatory guidelines and client expectations in medical writing.
Project Management:
Stay within budgeted hours for assigned projects and communicate any scope changes to leadership.
Complete required administrative tasks in a timely manner.
Professional Development:
Pursue ongoing training to stay updated with regulatory and industry trends.
Additional Duties:
Perform other job-related duties as assigned.
Minimal travel may be required (<25%).
Qualifications
Education:
Bachelor’s degree in Science, English, Communications, or Social Sciences with relevant writing experience.
Skills:
Extensive knowledge of English grammar, FDA, and ICH regulations, and AMA style guidelines.
Proficiency in Microsoft Word, Excel, PowerPoint, and Internet usage.
Familiarity with clinical research principles and ability to present complex data effectively.
Experience:
Strong leadership, presentation, and proofreading skills with a team-oriented approach.
Ability to interpret and create detailed clinical documentation.
Why Syneos Health?
Global Impact: Be part of a team contributing to groundbreaking biopharmaceutical projects, improving patient lives worldwide.
Career Growth: Access technical and therapeutic training, peer recognition, and clear career progression paths.
Inclusive Culture: Thrive in a diverse and supportive workplace where authenticity and collaboration are valued.
Comprehensive Benefits: Enjoy competitive compensation, health benefits, flexible paid time off, and professional development opportunities.
Location: Home-Based, India
Updated: December 2, 2024
Job ID: 24006190
Join Syneos Health to advance your career in medical writing while making a meaningful difference in the healthcare industry. Apply Today!
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