Leeann Bonaventura
Frederick,MD
Summary
Methodical Director with 10+ years of comprehensive experience overseeing daily operations of biopharmaceutical company or organization. Hardworking and versatile professional well-versed in executing business strategies, preparing and implementing business plans and overseeing financial performance. Thorough knowledge of market changes and trends paired with strong grasp of corporate finance and performance measures.
Overview
17
17
years of professional experience
Work History
Director, Promotional Regulatory Affairs
AstraZeneca
Gaithersburg, MD
03.2018 - Current
- Responsible for implementing multiple FDA policies regarding advertising and promotion of prescription drugs. Lead review of promotional materials for healthcare, payer, and consumer audiences for billion-dollar oncology franchise, including review of websites, speaker decks, physician and patient brochures and educational materials, and social media. Launched 10+ new indications. Annually review 1k+ materials.
- Lead educational initiatives for marketing, medical and agency partners to improve adherence to FDA policies around proactive communications of prescription drugs as well as policies regulating scientific exchange and medical education. Lead monthly "Coffee Talk" trainings as well as develop and deliver live and computer-based trainings to cross-functional partners.
- Recruited, trained, supervised, evaluated and mentored new staff members.
- Co-chapter lead of Medical Affairs Women's Leadership Initiative (MAWLI). Lead monthly calls and initiatives to support career growth and mentorship for women working in Medical Affairs.
- STEMbassador volunteer. Partner with compan program to provide career mentorship in STEM to rising high school and college students
- Member Healthcare Business Women's Association
Associate Director, Regulatory Affairs
AstraZeneca
Gaithersburg, MD
06.2011 - 03.2014
- Reviewed pipeline materials (Phase II and earlier) across various therapeutic areas including oncology, respiratory, infectious diseases, and autoimmune diseases to ensure adherence to FDA policies regarding scientific exchange. Reviewed slide decks, conference exhibits, publications and press materials. Regularly partnered with senior scientific leadership to ensure materials adhered to FDA policies.
- Created effective communication channels between different departments in order to facilitate collaboration.
- Developed training programs for cross-functional partners as well as new hires.
Senior Manager, Commercial Operations
AstraZeneca
Gaithersburg, MD
03.2008 - 06.2011
- Developed and implemented strategies to improve operational efficiency, reduce costs, and increase productivity.
- Wrote SOPs and Operations Manuals to streamline efficiencies for review of promotional materials.
- Developed and implemented trainings for stakeholders and cross-functional partners to understand promotional review process.
- Won company-wide award (Esprit de Corps) for streamlining and improving process for promotional review.
Senior Associate, Commercial Operations
Biogen
Boston, MA
05.2007 - 02.2008
- Identified cost savings opportunities through process optimization, including creating a marketing and style guide for agencies.
- Created a reference and claims guide for reviewers and agency partners to streamline reviews.
- Organized and conducted meetings for review of promotional materials.
- Developed trainings of promotional review process for cross-functional stakeholders.
Education
Ph.D. - Behavioral Neuroscience
SUNY At Binghamton
Binghamton, NY12-2007
Bachelor of Arts - Psychobiology/English
Lafayette College
Easton, PA05-1998
Skills
- Legal and Regulatory Compliance
- Project Coordination
- Staff Development
- Cross-functional team leadership
- Strategic Planning
- Company guidelines
- Training and development
- Charismatic Leader
Affiliations
- Mentor for Woman to Woman Mentoring since 2016. Mentor for both CORE and STEM programs. Member of Pop-Up Shop Committee.
- Lafayette College Career Mentorship program since 2008
Timeline
Director, Promotional Regulatory Affairs
AstraZeneca
03.2018 - Current
Associate Director, Regulatory Affairs
AstraZeneca
06.2011 - 03.2014
Senior Manager, Commercial Operations
AstraZeneca
03.2008 - 06.2011
Senior Associate, Commercial Operations
Biogen
05.2007 - 02.2008
Ph.D. - Behavioral Neuroscience
SUNY At Binghamton
Bachelor of Arts - Psychobiology/English
Lafayette College