Senior Medical Writer (CTT)

About the Role

The role entails day-to-day management of medical writing activities, including drafting, reviewing, and workflow management. You will also be responsible for coordinating quality and editorial reviews, ensuring that source documentation is managed appropriately. As a Senior Medical Writer, you will be expected to mentor and lead less experienced medical writers on complex projects, providing technical support, training, and consultation to department and other company staff.

Syneos Health's Clinical Development model brings the customer and patient to the center of everything that the company does. As a Senior Medical Writer, you will be part of a team that is passionate about developing innovative solutions to address modern market realities. You will have the opportunity to work on a wide range of projects, from clinical study protocols to journal manuscripts and abstracts, posters, and presentations for scientific meetings.

What You Will Do

• Lead the development of high-quality medical writing deliverables, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings
• Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision
• Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately
• Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format
• Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs
• Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff
• Mentor and lead less experienced medical writers on complex projects
• Develop deep expertise on key topics in the industry and regulatory requirements
• Work within budget specifications for assigned projects

What We Are Looking For

• Bachelor's degree in a relevant discipline with relevant writing experience
• Minimum 4 years of relevant experience in disclosure platform
• Good experience in drafting, review, and workflow in disclosure platform like disclose/PRIME etc.
• Hands-on experience with user acceptance testing activities
• Strong understanding of regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides
• Excellent writing and editing skills, with the ability to present scientific information clearly and accurately
• Strong analytical and problem-solving skills, with the ability to coordinate quality and editorial reviews
• Ability to work independently and as part of a team, with minimal supervision
• Strong communication and interpersonal skills, with the ability to build good working relations with clients, department heads, and peers

Nice to Have

• Experience with other disclosure platforms, such as Medidata or ClinOne
• Knowledge of regulatory requirements for clinical trials, including ICH E6 and 21 CFR Part 11
• Familiarity with statistical analysis plans and table/figure/listing specifications
• Experience with online clinical literature searches and compliance with copyright requirements
• Certification in medical writing, such as the Certified Medical Writer (CMW) or the Diplomate of the American Medical Writers Association (DAMWA)

Benefits and Perks

• Competitive salary and benefits package
• Opportunity to work with a leading fully integrated biopharmaceutical solutions organization
• Collaborative and dynamic work environment that fosters career growth and innovation
• Access to training and development opportunities, including technical and therapeutic area training
• Recognition and reward programs, including peer recognition and total rewards program
• Flexible work arrangements, including remote work options
• Comprehensive health and wellness programs, including mental health support and employee assistance programs
• Paid time off and holiday leave, including flexible vacation days and sick leave

• Make sure to highlight your experience with disclosure platforms, such as disclose/PRIME, in your resume and cover letter.
• Showcase your writing and editing skills by including samples of your work, such as clinical study protocols or journal manuscripts.
• Be prepared to discuss your understanding of regulatory standards, including ICH E3 guidelines and company standard operating procedures.
• Emphasize your ability to work independently and as part of a team, with minimal supervision.
• Be ready to talk about your experience with statistical analysis plans and table/figure/listing specifications.
• Research the company's culture and values, and be prepared to discuss how you align with them.
• Practice your communication and interpersonal skills, as you will be working with clients, department heads, and peers in a remote work environment.