Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Over

About the Role

The regulatory writing team at Syneos Health is committed to delivering high-quality documents that meet the needs of regulatory agencies worldwide. As a Sr. Principal Medical Writer, you will have the opportunity to work on a variety of projects, from clinical trial reports to marketing authorization applications. Your attention to detail, organizational skills, and ability to work under tight deadlines will be essential in this role.

Syneos Health offers a supportive and inclusive work environment that fosters growth and development. As a remote worker, you will have the flexibility to work from anywhere, while still being connected to a global team of experts. With a strong focus on work-life balance, Syneos Health provides a range of benefits and perks that cater to the needs of its employees.

What You Will Do

• Develop high-quality regulatory documents for submission to global agencies, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews
• Manage medical writing projects, including developing timelines, communicating with cross-functional team members, and maintaining awareness of review cycles and expectations
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and processes
• Review other documents associated with assigned projects, such as protocols and statistical analysis plans
• Collaborate with study teams to develop and implement regulatory writing plans
• Ensure compliance with ICH guidelines, Syneos Health's authoring standards, and regulatory agency requirements
• Develop and maintain a thorough understanding of regulatory requirements, including eCTD submissions
• Provide training and guidance to junior medical writers as needed
• Participate in process improvement initiatives to enhance the efficiency and quality of regulatory writing

What We Are Looking For

• Bachelor's degree in life sciences, pharmacy, or a related field
• Minimum 8 years of experience in medical writing, with a focus on regulatory documents
• Strong knowledge of ICH guidelines, regulatory agency requirements, and eCTD submissions
• Excellent writing, editing, and communication skills
• Ability to work independently and collaboratively as part of a global team
• Strong organizational and project management skills, with attention to detail and ability to meet deadlines
• Experience with regulatory writing software and tools, such as DocuSign and Adobe Acrobat
• Strong analytical and problem-solving skills, with the ability to interpret complex data and develop clear, concise reports

Nice to Have

• Experience in oncology or a related therapeutic area
• Knowledge of Syneos Health's authoring standards and style guides
• Certification in medical writing, such as the Board of Editors in the Life Sciences (BELS) or the American Medical Writers Association (AMWA)
• Experience with process improvement initiatives and quality assurance

Benefits and Perks

• Competitive salary range, with opportunities for growth and advancement
• Comprehensive benefits package, including medical, dental, and vision insurance
• 401(k) matching program, with opportunities for employee stock purchase
• Flexible paid time off and sick leave, with a focus on work-life balance
• Opportunities for professional development and continuing education
• Remote work options, with the ability to work from anywhere
• Collaborative and inclusive work environment, with a focus on diversity and inclusion
• Recognition and reward programs, including employee awards and bonuses
• Access to cutting-edge technology and tools, including regulatory writing software and platforms
• Opportunities for career advancement and leadership development

• Develop a strong portfolio of regulatory writing samples, including Clinical Study Reports and Clinical Summaries of Efficacy and Safety
• Familiarize yourself with ICH guidelines and regulatory agency requirements, including eCTD submissions
• Invest in continuing education and professional development, including certifications in medical writing
• Network with other medical writers and regulatory professionals to stay up-to-date on industry trends and best practices
• Be prepared to discuss your experience with regulatory writing software and tools, including DocuSign and Adobe Acrobat
• Highlight your attention to detail and ability to work under tight deadlines, as these are essential skills for a Sr. Principal Medical Writer
• Research Syneos Health's company culture and values, and be prepared to discuss how your skills and experience align with these