Job Title:
Senior Principal Medical Writer
Location:
Remote – Delaware, USA
Job ID:
25101798
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by combining clinical, medical affairs, and commercial expertise. Our Clinical Development model centers on patients and customers, streamlining processes to deliver therapies efficiently.
Learn more: Syneos Health
Job Summary:
The Senior Principal Medical Writer (Associate Director level) develops, leads, and oversees the preparation of clinical documents for global regulatory submissions. This role provides strategic direction to cross-functional project teams, ensures scientific rigor, and mentors junior medical writers while managing multiple compounds and high-complexity writing projects.
Key Responsibilities:
Develop regulatory documents for global submissions in compliance with ICH guidelines, corporate objectives, and study/project timelines.
Manage medical writing projects, including creating timelines, coordinating cross-functional review cycles, and communicating expectations with team members.
Participate in cross-functional meetings to provide input on medical writing deliverables, timelines, and processes.
Review project-related documents (e.g., Protocols, Statistical Analysis Plans) for accuracy and completeness.
Contribute to cross-functional process improvement initiatives.
Define and write standard operating procedures (SOPs) and best practices to enhance efficiency in document preparation.
Manage internal and contract medical writing resources to ensure timely project completion.
Mentor and guide junior medical writing staff.
Qualifications:
Broad understanding of clinical research processes and global regulatory document standards.
Experience developing clinical documents such as Investigators’ Brochures (IBs), Clinical Study Reports (CSRs), marketing authorization submission documents, and other regulatory deliverables.
Ability to provide strategic direction and leadership to medical writing teams.
Skills & Competencies:
Strong scientific writing and communication skills.
Leadership and mentorship capabilities.
Ability to manage multiple compounds and complex projects.
Knowledge of regulatory standards for global submissions.
Attention to detail and accuracy in data presentation and interpretation.
Impact and Contribution:
Ensures clinical documents accurately and consistently present data-driven clinical messages aligned with program goals.
Oversees multiple writing projects and serves as lead writer for summary documents.
Mentors less experienced writers, promoting team development and adherence to quality standards.
Reports to Director of Medical Writing or above.
Job Category:
Medical Writing / Regulatory Affairs / Clinical Documentation
Salary Range:
$114,000 – $210,900 per year
(Actual salary may vary based on qualifications, skills, and experience.)
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Canada |Quebec :
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Greece |North Island :
Auckland |New Zealand :
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Tallinn |Hà Nội :
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