+ Years of professional experience
Neal Azrolan PhD MBA
Riegelsville,PA
Summary
Senior Medical & Scientific Communications Leader, Regulatory Affairs Expert, and Publication Strategist with experience in medical writing across scientific, clinical, regulatory, and promotional sectors. Accomplishments include leadership in the approval and commercialization of major therapeutics such as ADCETRIS, TAFAMIDIS, DUAVIVE, ISENTRESS, and ZOSTAVAX. Expertise in leading publication strategy, authoring safety, efficacy, and clinical pharmacology summaries, and managing regulatory submissions globally (FDA, EMA, Health Canada). Background in pharmaceutical industry at Merck, Pfizer, and Wyeth, with agency experience supporting diverse therapeutic areas including Oncology, Women's Health, Neurology, Infectious Diseases, Cardiovascular, and Immunology. Developed and led publication plans for over 10 drug franchises, authored over 60 peer-reviewed publications, created and reviewed promotional content, and served on promotional review committees. Holds a PhD in Biochemistry/Oncology and an MBA with a focus in Health Outcomes and Pharmacoeconomics. Academic appointments at The Rockefeller University, NYU, and other universities. Co-author of two cardiovascular treatment patents and active in community service through music and nonprofit board leadership.
Overview
30
30
Work History
Consultant/Medical Writer
DACHS Computing and Biosciences
07.2021 - Current
- Medical Writing for Software Product Development and Marketing for OnStyle Software
- Create/contribute to medical writing software Publications/Newsletters with an experienced medical writer perspective
- (July 2021 to April 2022) Future Medical Writing Paradigms and Changes in Medical Writing Software Including AI, (May 2022 to January 2023) Medical Writing Challenges and OnStyle Software Solutions
- (February 2023 to January 2025) Facilitation of Hyperlinking, Abbreviations and other Writing Functions in Regulatory Summaries and CSRs using Onstyle Software, (January 2025 to Present) Expanded Use of QR Codes in Drug Labelling
Associate Director, Regulatory Affairs, Medical Writing, Internal Medicine
Pfizer
01.2013 - 07.2019
- Create/contribute to strategy, author, review, and revise regulatory documents and responses to regulatory agencies that are compliant with Pfizer Regulatory SOPs and relevant ICH and regulatory agency guidelines
- Manage review process for medical agency safety and efficacy responses
- Convene and lead response teams
- Contribute to data interpretation
- Manage adjudication of reviewer comments, reviews, and approval process
- Communicate resource, timeline, and pertinent clinical data issues that impact regulatory needs
- Develop and maintain collaborative relationships with clinical, scientific, bio-statistical, clinical pharmacology, regulatory, and project managers for the efficient development of quality regulatory documents
- Specific regulatory document experience
- Clinical Overviews
- Responses to medical agencies
- Agency meeting briefing documents
- Fast Track Designation Requests
- Essential Medicine List Applications (WHO)
- Submission Convention Guides
- Submission Key Messages for authors and management
- Summaries authored:
- Summary of Clinical Safety (SCS)
- Integrated Summary of Safety (ISS)
- Summary of Clinical Pharmacology (SCP)
- Summary of Clinical Efficacy (SCE)
- (Dec 2018 to Jul 2019), Hormonal/Diabetes/Metabolic/Women’s & Sexual Health (2013 to 2016), Rare Diseases (2016 to 2018)
Medical Affairs, Promotional Review and Publication Planning, Oncology
Seattle Genetics
09.2011 - 01.2013
- Publication planning and strategy for ADCETRIS (brentuximab vedotin) and pipeline biologics
- Create, review, and revise promotional documents (sales/MSL training, monographs, website content)
- Respond to FDA DDMAC comments (member promotional review committee)
- Create and review Customized Medical Response Letters
- Create and review MSL presentations and promotional training materials
- Remote
Executive Director, Scientific Services
Oxford PharmaGenesis
01.2010 - 12.2010
- Creation and review of non-promotional manuscripts, presentations, and other scientific, clinical, EBM and marketing communications
- Mentor medical writers
- Publication strategy and planning
- Advisory Board (Clinical/HE&OR)
- Content and scientific review
- Work with clients/KOLs to develop slide and program content and ensure that client’s needs are met
- Direct and create slides for presentations/discussions
- Responsible for implementing strategic objectives for Evidence-based medicine (EBM; i.e. Modeling, outcomes research, Health technology assessments, advisory boards)
Medical/Scientific Consultant
Phocus
01.2009 - 02.2009
- Creation/development of manuscripts for submission to LANCET
- Creation/training of scientific writers
- Medical review of slide sets and other deliverables
- Clinical projects:
- Oncology (metastatic breast cancer)
- Metabolic diseases (Diabetes mellitus)
- Consulting Contract Projects (some overlapping)
Associate Director, Medical Communications, Clinical & Quantitative Sciences
Merck Research Labs
01.2005 - 01.2008
- Chairman, Publication Team /Product Development Team for ISENTRES (Raltegravir)
- Developed, coordinated and implemented publication strategies for Isentress (Raltegravir) relative to product life cycle needs (pre-launch, launch, post-launch & Phase V plans)
- Interacted with the associated Commercialization Teams and the Worldwide Business Strategy Teams to prioritize publication and promotional activities.
- Identified key data/issues for publications, defined hypotheses and sources of data, reviewed data analysis plans
- Directed team in writing manuscripts, developing posters/oral presentations, graphic displays and slide sets for KOL educational activities (CME)
- Created/presented presentations for scientific forums/congresses/advisory boards
- Participated in marketing-organized meetings, both domestic and international.
- Contributed to development and CME content maintenance of the Merck Scientific Leadership Website (Merck Scientific Leadership Initiative)
- Member/advisor of publication subteams (including: HIV Vaccines, ZOSTAVAX)
- Managed/mentored direct reports
- Managed and reviewed vendor (agency) services for Merck
- Contributed to the development, and implementation of departmental and company-wide publication guidelines
- Transparency, Authorship, Timelines, Review
- Revised/Approved prepublication manuscripts
Associate Director, Worldwide Editing, Global Strategic Regulatory Development (GSRD)
Merck Research Labs
01.2004 - 01.2005
- Directed and mentored clinical regulatory writers for both CSRs and labeling. Contributed to the development and writing of clinical study reports (CSRs)
- Consulted with authors of regulatory documents to resolve scientific, regulatory and editorial issues and assisted with the training of labeling personnel and authors of regulatory documents
- Participated in the development and medical review of product circulars for new products, submitted as part of Worldwide Marketing Applications (WMAs) and Biologics License Applications (BLA), as well as for new indications and claims, submitted as part of supplemental WMAs and BLAs
- Served as core member on labeling task forces, Label Evaluation and Development (LEAD) Teams, Global Regulatory (GRT) Teams and planning and tracking teams
- Scientific reviewer of regulatory documents included in marketing applications
- Reviewed and approved revisions for domestic (i.e. headquarters, USPPI, USPI) as well international (i.e. subsidiary, EUPPI, EUPC) Merck & Co., Inc. labels
- Contributed to the review and discussion of relevant regulatory issues as a member of the Global Regulatory Strategic Review Committee
- Reviewed and approved prepublication manuscripts
Principal Research Scientist Cardiovascular and Metabolic Disease Vascular Biology Research Group
Wyeth Research
07.1995 - 01.2004
- Managed in vivo Cardiovascular Research group
- Researched, developed and employed appropriate paradigms for the study of atherosclerosis, lipoprotein metabolism and the evaluation of cardiovascular endpoints
- Studied the etiology of CV disease for the purposes of both defining molecular mechanistic properties of proprietary compounds, as well as the exploration and development of novel therapeutic targets
- Provided research support for the preclinical and clinical progress of proprietary compounds
- Managed/mentored direct reports
- Managed and promoted external collaborations with academic clinical and preclinical investigators
- Evaluated potential in-licensing candidates
- Contributed to the development and scientific review of NDAs
- Published, managed scientific manuscripts and presentations in support of Wyeth Research
Assistant Professor, Biochemical Genetics & Metabolism
The Rockefeller University
01.1991 - 01.1995
Postdoctoral Fellow, Biochemical Genetics & Metabolism
The Rockefeller University
01.1987 - 01.1991
Adjunct Professor, Department of Genetics
New York University
01.1987 - 01.1989
Education
MBA - Health Care Administration & Pharmacoeconomics
Rider University
Lawrenceville, NJ01.2002
PhD - Biochemistry/Cell Biology, Oncology
New York University
New York, NY01.1987
MS - Biochemistry/Cell Biology, Liver and Cancer Cell Biochemistry and Metabolism
New York University
New York, NY01.1983
MS - Plant Biochemistry, Photosynthetic and Accessory Pigment Biochemistry
Virginia Commonwealth University/Medical College of Virginia
Richmond, VA01.1981
BS - Biology/Geology, concentrations in Marine Biology and Geology
Brooklyn College
Brooklyn, NY01.1979
Skills
- Clinical documentation
- Promotional review
- Clinical document editing
- Skill enhancement facilitation
- Strategic issue analysis
- Detail-oriented approach
- Effective team leadership
- Client engagement
Accomplishments
Patents
- US 6,670,355 Method of Treating Cardiovascular Disease
- WO 0,197,809 Method of Treating Cardiovascular Disease Using Rapamycin
Community Service
Board Member for non-profit Organizations:, The Laurel Education Group (Board member at large, Board of trusties), The Blawenburg Band (President, Board of Directors), Easton Municipal Band (Board member at large), Musician, Central Jersey Saxophone Quartet, Lawrenceville Community Band, The Whitehouse, Wind Symphony, The Blawenburg Band, Easton Municipal Band, Scientific Liaison Lawrence Township (NJ) Public School System, Coach Princeton Youth Hockey Association
Publications
Available upon request
Timeline
Consultant/Medical Writer
DACHS Computing and Biosciences
07.2021 - Current
Associate Director, Regulatory Affairs, Medical Writing, Internal Medicine
Pfizer
01.2013 - 07.2019
Medical Affairs, Promotional Review and Publication Planning, Oncology
Seattle Genetics
09.2011 - 01.2013
Executive Director, Scientific Services
Oxford PharmaGenesis
01.2010 - 12.2010
Medical/Scientific Consultant
Phocus
01.2009 - 02.2009
Associate Director, Medical Communications, Clinical & Quantitative Sciences
Merck Research Labs
01.2005 - 01.2008
Associate Director, Worldwide Editing, Global Strategic Regulatory Development (GSRD)
Merck Research Labs
01.2004 - 01.2005
Principal Research Scientist Cardiovascular and Metabolic Disease Vascular Biology Research Group
Wyeth Research
07.1995 - 01.2004
Assistant Professor, Biochemical Genetics & Metabolism
The Rockefeller University
01.1991 - 01.1995
Postdoctoral Fellow, Biochemical Genetics & Metabolism
The Rockefeller University
01.1987 - 01.1991
Adjunct Professor, Department of Genetics
New York University
01.1987 - 01.1989
PhD - Biochemistry/Cell Biology, Oncology
New York University
MS - Biochemistry/Cell Biology, Liver and Cancer Cell Biochemistry and Metabolism
New York University
MS - Plant Biochemistry, Photosynthetic and Accessory Pigment Biochemistry
Virginia Commonwealth University/Medical College of Virginia
BS - Biology/Geology, concentrations in Marine Biology and Geology
Brooklyn College
MBA - Health Care Administration & Pharmacoeconomics
Rider University
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