Director / Senior Director, Regulatory Medical Writing (Remote)
Position Overview :
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
Senior Medical Director, Late Stage PST (Product Safety Lead) - Oncology
The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS. Lead ...
Senior Director, National Field Medical Affairs, Oncology
In addition to leading and supporting the Field Medical teams, the Senior Director, National Field Medical Affairs, Oncology also serves as a Strategic Priority Owner of other Field Medical and broader guardant health initiatives. Bring innovation and energy as a core member of the Medical Affairs l...
Senior Director, Medical & Patient Affairs
Senior Director, Medical & Patient Affairs. Define and implement a strategic plan for one or more of Encoded’s clinical development programs in close collaboration with Scientific Communications, Clinical Development and the wider Medical Office, including Publication Planning, Medical and Scien...
Senior Director, Marketing
The Senior Director of Marketing will lead the development and implementation of marketing strategies to support HEPLISAV-B in the US Market inclusive of customer strategies for IDN, retail, public sector, and the broader ecosystem. Work cross-functionally by partnering with Medical Affairs, Regulat...
Medical Director - Premise Health
Experience:3 – 5 years minimum in family practice, emergency room, ambulatory care, or occupational health settingsMinimum 3 years management/leadership experience within the healthcare industry may be preferred Knowledge and Skills:Demonstrated interpersonal and collaboration skillsSuperior verbal ...
Associate Director, Patient Advocacy and Community Engagement (hybrid or remote)
We’re looking for an Associate Director of Patient Advocacy and Community Engagement to join our Clinical Development Team. Navigate all your interactions with patient communities and advocacy groups with the highest ethical standards, keeping everything above board with GCP, regulatory guidelines, ...
Sr Resident Care Director - RN
At Sunrise, our Senior Resident Care Director (Sr. Sunrise Senior Living has championed quality of life in senior care for more than 30 years. Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. Managing all clinical programs, quality assurance and regulatory c...
Medical Director
Premise Health is seeking a full time Medical Director to provide primary care and clinical leadership with our employer based direct care clinic in Sunnyvale, CA . Conducts histories, physical exams and prescribes medical treatment. Knowledge and experience with electronic medical records strongly ...
Client Services Director - Medical Communications - Remote
Continuing their growth, the team are excited to bring on someone new to join their Director-level leadership team, in the form of an Client Services Director! As Client Service Director, you'll bring a wealth of experience in the medical communications industry, leading and driving multiple account...
Culinary Service Director
Integral Senior Living, proudly part of the Discovery Senior Living family of operating companies, manages care and lifestyle-focused senior living communities. Integral Senior Living is looking for a Director of Culinary Services - Fine Dining to join our community ***. Does working for the leader ...