Sponsor Dedicated - Sr. Principal Medical Writer - Regulatory Submission Docs (ISE/ISS/Clinical Overview - Must Have)

Responsibilities

• Develop regulatory documents for global submission in line with ICH guidelines and client authoring standards

• Manage medical writing projects, timelines and cross-functional communication through review cycles

• Participate in cross-functional meetings on deliverables, timelines and processes

• Review protocols and statistical analysis plans for assigned projects

• Define standard operating procedures and best practices for quality document preparation

• Manage internal and contract medical writing resources

• Mentor more junior medical writing staff

Requirements

• Bachelor's degree required

• At least 5 years of medical writing experience in biopharma/CRO or comparable clinical or preclinical development

• Proficiency organizing and communicating clinical information with minimal oversight

• Strong organizational, time management and project management skills

• Strong verbal, written and interpersonal communication skills

• Proficient understanding of global regulatory requirements

• Proficient in MS Word and experience with electronic document management systems and templates

Preferred Qualifications

• Oncology experience

• Advanced degree in a relevant scientific, clinical or regulatory field

• Knowledge of therapeutic areas across all phases of clinical development

About the Company

Syneos Health is a fully-integrated life sciences services organization that partners with innovators across drug development and commercialization.