Rosanne Lewis
Horsham,PA
Summary
Doctor of Pharmacy with 20+ years of progressive experience in Medical Information, Regulatory Affairs, and Clinical Pharmacy across retail, hospice, and global pharmaceutical companies. Skilled in developing and reviewing scientific and regulatory content, managing payer and health system requests, and ensuring compliance with healthcare regulations. Recognized for medical writing, cross-functional collaboration in matrix environments, and payer-focused communication strategies. Passionate about advancing innovative medicine and improving access to care.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Regulatory Affairs Specialist, GRACS CMC Post Approval
Merck & Co., Inc.
, United States
04.2025 - Current
- Act as liaison for the Submission Enablement Team, ensuring prompt clinical trial and marketing application processes.
- Lead procurement/tracking of ancillary documents to support regulatory submissions.
- Collaborate across functions to streamline communication and resolve conflicts, improving efficiency.
Clinical Pharmacist
Ascend Wellness Holdings
, United States
11.2022 - Current
- Ensured compliance with state regulations for medical cannabis patients.
- Conducted patient consultations and tailored therapy recommendations.
- Collaborated with leadership to improve care delivery and operational efficiency.
Regulatory Affairs Liaison, GRACS SSDM
Merck & Co., Inc.
, United States
09.2023 - 03.2025
- Supported operational aspects of clinical trial and marketing submissions for multiple regions.
- Coordinated post-approval activities including marketing authorization renewals and transfers.
- Enhanced submission efficiency, ensuring regulatory compliance and timely approvals.
Senior Clinical & Regulatory Analyst III
Merck & Co., Inc.
, United States
11.2021 - 09.2023
- Supported regulatory operations and document management for global submissions.
- Partnered with stakeholders to resolve issues and drive prompt approvals.
- Led cross-functional meetings to improve submission workflows.
Clinical Pharmacist
The Apothecarium
Plymouth Meeting, United States
09.2019 - 03.2022
- Delivered patient and caregiver consultations with emphasis on accuracy and compassion.
- Mentored staff on compliance and best practices.
- Conducted research and published case studies in medical cannabis therapy.
Clinical Pharmacist, Fulfillment Specialist, Home Agent
Humana / Enclara Pharmacia (formerly excelleRx)
PA, United States
10.2005 - 09.2021
- Served as palliative care clinician specializing in hospice patients’ symptom management.
- Provided consultative guidance to physicians and caregivers on treatment strategies.
- Compounded medications, navigated drug shortages, and ensured compliance with regulations.
- Partnered with healthcare professionals to optimize therapy and improve outcomes.
Staff Pharmacist / Pharmacy Manager / Implementation Specialist
Acme Markets, Eckerd Drug, Superfresh, Rite Aid
PA, United States
01.2000 - 01.2007
- Managed high-volume retail pharmacy operations, filling up to 1,400 prescriptions weekly.
- Trained, scheduled, and supervised pharmacists and technicians.
- Increased formulary adoption and implemented regulatory compliance measures for newly acquired pharmacies.
- Delivered consistent patient care and operational excellence.
Pharmacy Intern
Jefferson Healthcare (Frankford Torresdale Hospital)
Philadelphia, United States
01.1996 - 01.1998
Education
MBA - Healthcare Administration/Management
Holy Family University
Doctor of Pharmacy -
University of Florida
BS - Pharmacy (Minor: Sociology)
University of the Sciences in Philadelphia
Skills
- Medical Information
- Document management
- Payer Engagement
- Health Systems Engagement
- Regulatory Submissions
- Post-Approval Support
- Voice of Customer Insights
- Metrics Tracking
- Clinical Decision Resource Organization Support
- Cross-Functional Leadership
- Matrix Teams
- Hospice Care
- Palliative Care Expertise
Certification
- Pharmacist License (Active) in PA, NJ, DE & ME.
- Certificate of Achievement, Pharmacy-Based Immunization Delivery in PA
- Notary Public in PA
- Basic Life Support (BLS) Certification
Core Expertise
- Medical Information
- Payer & Health Systems Engagement
- Regulatory Submissions & Post-Approval Support
- Voice of Customer Insights & Metrics Tracking
- Clinical Decision Resource Organization (CDRO) Support
- Cross-Functional Leadership in Matrixes Teams
- Hospice & Palliative Care Expertise
Timeline
Regulatory Affairs Specialist, GRACS CMC Post Approval
Merck & Co., Inc.
04.2025 - Current
Regulatory Affairs Liaison, GRACS SSDM
Merck & Co., Inc.
09.2023 - 03.2025
Clinical Pharmacist
Ascend Wellness Holdings
11.2022 - Current
Senior Clinical & Regulatory Analyst III
Merck & Co., Inc.
11.2021 - 09.2023
Clinical Pharmacist
The Apothecarium
09.2019 - 03.2022
Clinical Pharmacist, Fulfillment Specialist, Home Agent
Humana / Enclara Pharmacia (formerly excelleRx)
10.2005 - 09.2021
Staff Pharmacist / Pharmacy Manager / Implementation Specialist
Acme Markets, Eckerd Drug, Superfresh, Rite Aid
01.2000 - 01.2007
Pharmacy Intern
Jefferson Healthcare (Frankford Torresdale Hospital)
01.1996 - 01.1998
MBA - Healthcare Administration/Management
Holy Family University
Doctor of Pharmacy -
University of Florida
BS - Pharmacy (Minor: Sociology)
University of the Sciences in Philadelphia
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