Amro Ali Email & Phone Number

Watertown, Ma, Us

Watertown, Ma, Us

Watertown, Ma, Us

Raritan, New Jersey, Us

Raritan, New Jersey, Us

• Developed a Phase III non-inferiority study protocol element document (PED) for submission to the internal protocol review committee.• Medically monitored adverse events, ECG values, physical examinations, and general medical history throughout a Phase IV pharmacokinetic (PK) bioequivalence (BE) study to ensure safety and protocol adherence.• Provided clinical input within the compound development team (CDT) for amendment of the Investigator Brochure, Informed Consent Form, and Protocol of a Phase IV PK BE study.• Edited and reviewed a Plan Language Summary (PLS) for a phase IV PK BE study.• Developed a clinical study design and regulatory strategy that was presented to upper management of Global Public Health (GPH) and Established Products (EP).• Actively participated and provided clinical input within Safety Management Team meetings for newly reported adverse effects. • Reviewed abstracts for inclusion in the clinical bibliography annual report of multiple women’s health/urology products. • Collaborated with the regulatory team to compare regulatory pathways for health authorities such as EMA, FDA, and Swissmedic for a GPH/EP product. • Reviewed and developed EMA scientific advice questions from a clinical and a statistical perspective in preparation for an EMA scientific advice meeting. • Worked closely with the statistical team to develop non-inferiority margins and sample size calculations regarding both a binomial and lognormal analysis of continuous data. • Completed weekly literature reviews and disseminated salient publications to CDT.

Woonsocket, Rhode Island, Us

• Counseled patients on drug therapy to provide information regarding adverse effects, proper administration, and storage. • Ran and facilitated new prescriptions to production at drop off at highest volume store in the district.

Paris, France, Fr

• Developed and presented a summary and analysis of the updated FDA guidance for Rare Diseases: Common Issues in Drug Development to educate the Regulatory Affairs team.• Presented a NEJM review article regarding The Changing Face of Clinical Trials: Evidence for Health Decision Making- Beyond RCT’s to educate the Regulatory Affairs team.• Updated a master label document containing all enzyme replacement therapies (ERT) and provided class labeling suggestions regarding all ERTs to assist in label development of two products in launch phase.• Reviewed and provided suggestions to shorten the Important Safety Information (ISI) for an MS product to assist the commercial team in patient advertisement materials.

Paris, France, Fr

• Developed a Medical Affairs Strategy for a Phase I/II genome editing product for the treatment of beta-thalassemia.• Created a comprehensive report of ADPKD abstracts presented at the 2018 American Society of Nephrology Congress for internal education of the Medical Affairs Team.• Presented a journal club to fellows regarding gene therapy on beta-thalassemia to understand the competitive landscape of a pipeline product.• Updated monthly literature reviews on MPS I/II for internal education of the Medical Affairs team.

Baltimore, Md, Us

• Aided in auditing of health plans regarding grievances, appeals, and denials to ensure compliance.• Presented to all regional CMS pharmacists on DIR fees and their impact on community pharmacies.• Presented to 150 stakeholders regarding Medicare 2019 rollout changes to ensure effective transition and transparency.• Participated in the discussion of the 2019 Health Plan Coverage at Blue Cross Blue Shield Rhode Island to guarantee CMS compliance.

Hartford, Ct, Us

• Created patient-friendly handouts regarding smoking cessation products and education to help promote lifestyle changes.• Interviewed patients and evaluated their chronic medication therapy (i.e. diabetes, hypertension, osteoporosis, dyslipidemia, etc.).

Farmington, Connecticut, Us

• Presented to hospital pharmacists and the residency director on ACE-Inhibitor Induced Angioedema.• Lead topic discussions regarding alcohol withdrawal, hyponatremia, hypernatremia, and gastrointestinal disorders.• Presented patient cases on myasthenia gravis, endocarditis, and stress dose steroids.

Doctor Of Pharmacy (Pharm.D.), Pharmacy

High School