The position, reporting to the Sr. Director, Head of Global Regulatory Portfolio Management, with a dotted line reporting to the Interim Head of Medical Writing, will be the medical writing lead for clinical regulatory documents. A successful medical writer will be able to write independently and work effectively with cross-functional colleagues to develop documents efficiently and with high quality. This lead medical writer will lead submissions and oversee the selection and management of internal and contract medical/regulatory writers and organizations.
Responsibilities
In collaboration with key functional leaders for program teams, including Regulatory Affairs, Clinical Development, Clinical Operations and Research/Translational Sciences, plan, develop, and deliver high quality documents aligned with development program strategies and timelines
Lead the preparation, review, QC, and finalization of key documents including clinical synopses, protocols and study reports, investigator brochures, modules/sections of INDs/CTAs/BLAs/MAAs, briefing packages and responses to regulatory agency requests, as needed
In partnership with Head of Medical Writing, manage outsourcing of document preparation, including writing, editing, review and QC by effectively planning, screening, and allocating internal or contract writers to ensure corporate and program objectives are met, in collaboration with global program teams and key functional areas
Effectively manage the simultaneous preparation of multiple documents within and across development programs at various stages of development to ensure timely document completion in accordance with respective program strategies
Support Head of Medical Writing to develop and maintain document templates, and ensure consistency between programs, as appropriate. Apply lessons learned across programs to maximize efficiency and accuracy of document preparation
Participate in process improvement initiatives including medical writing SOPs, templates, style and review guidelines, and other aspects of document management
Requirements
Education and Experience:
Advanced or bachelor’s degree in a scientific discipline; life sciences preferred
8+ years of clinical regulatory writing experience, preferably with at least 5+ years in a pharmaceutical or biotechnology company focused on novel therapies. Experience in rare diseases and/or neuroscience preferred
Experience in managing direct reports
Demonstrated hands on experience in the preparation, review, and completion of key clinical and regulatory documents, including clinical protocols and study reports, investigator brochures, briefing documents, and module 2 summaries
Supervised preparation of module 2 summarizes/module 5 reports for eCTD/NDA/BLA/MAA submission
Well versed in ICH guidelines for regulatory submissions (INDs/CTAs/BLAs/MAAs) and associated regulatory documents including clinical protocols/study reports and investigator brochures
Track record of effective collaboration on project teams, and across multiple organizational levels and functions.
Proven skills of strong document management and project management, along with initiative and ability to be productive with minimal supervision
Competencies And Attributes
Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and values – courageous, imaginative, selfless, and joyful
Ability to build and maintain effective partnerships, both internally and externally
Exceptional written and verbal communication skills and attention to detail essential; must display strong analytical and problem-solving abilities
Excellent planning and organizational skills, including the ability to support and prioritize multiple documents, as needed
Flexible; adapts work style to meet organization needs
Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
Dedicated to quality and reliability
Excellent computer skills (Veeva, SmartSheet, Microsoft Office Suite; Project and Visio experience a plus)
Approximately 5% optional travel is anticipated
Seniority level
Director
Employment type
Full-time
Job function
Legal
Industries
Staffing and Recruiting
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