Nicole Lynn, PharmD
Regulatory Writing Project Manager at Aleon Pharma International, Inc.- Claim this Profile
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English Native or bilingual proficiency
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Spanish Limited working proficiency
Topline Score
Bio
Credentials
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Basic Life Support (CPR & AED)
American Heart AssociationDec, 2018- Sep, 2024 -
APhA Pharmacy-Based Immunization Delivery Certification
American Pharmacists AssociationNov, 2018- Sep, 2024 -
Pennsylvania State Board of Pharmacy Licensed Intern
Pennsylvania State Board of PharmacyDec, 2016- Sep, 2024
Experience
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Aleon Pharma International, Inc.
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United States
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Pharmaceutical Manufacturing
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1 - 100 Employee
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Regulatory Writing Project Manager
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Jun 2020 - Present
• Review pre-IND Formal Meeting Requests between FDA and sponsors relating to the development and review of drug or biological products regulated by CDER and CBER.• Compose meeting packages summarizing information relevant to the product and any supplementary information needed to develop responses to issues raised by the requestor or review division.• Write and review Common Technical Document (CTD) modules 2 and 4 for Investigational New Drug applications (INDs).• Draft Investigator Brochures (IBs) compiling clinical and non-clinical data on investigational products that are relevant to studying their use in human subjects.• Author General Investigational Plans (GIPs) briefly describing the overall plan for investigating drug products for the following year, including rationale for studies, indications, general approach, and any risks based on toxicological data.• Draft initial pediatric study plans (iPSP) in accordance with PREA, FDASIA, and FDARA.• Prepare development safety update reports (DSURs) for periodic analysis of safety information crucial to the ongoing assessment of risk to trial subjects.• In charge of monitoring frequently asked questions (FAQs) from sponsors and implementing standard responses.
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Merck
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Global Regulatory Affairs and Clinical Safety Project Coordinator
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Jan 2020 - Jun 2020
• Assisted in the onboarding process for the next round of APPE pharmacy students.• Provided input in the delegation of tasks to meet project deadlines.• Created educational content on available 3D printing technologies and each of their commercial applications, particularly relating to current and future use for pharmaceuticals.• Evaluated the capabilities of a patented 3D-screen printing process and its application to Merck products.• Researched the use of nanoparticles for drug API and biologics.
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Global Regulatory Affairs and Clinical Safety Extern/Office of the Senior Vice President
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Oct 2019 - Dec 2019
• Compiled and assessed survey results from Latin American and Asian/Pacific countries on medical device regulatory pathways.• Contributed to the formal written response to FDA questions regarding the proper storage, transport, and supply chain integrity of Merck’s Drone Delivery Program for direct relief in natural disasters.• Evaluated and provided input about four promotional launch activities for a biosimilar drug.• Researched the viability and feasibility of 3D printing drugs, biologics, and human organs in the pharmaceutical industry and the current and future regulatory environment for each. • Utilized computer-aided-design (CAD) software to develop a tablet prototype to facilitate research into 3D printed tablets.• Researched the WHO prequalification process for vaccines and assisted in prelaunch activities for the Ebola vaccine.• Acted as the communications coordinator for the APPE rotation program, documenting student tours and participation in Rutgers’ Professional Development Day in social media posts.• Published an article for Merck’s Annual Report about the importance of making APPE rotations in the pharmaceutical industry available to all pharmacy students.
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CVS Pharmacy
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United States
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Pharmaceutical Manufacturing
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700 & Above Employee
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Pharmacy Intern
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Dec 2016 - Mar 2020
• Communicated with prescribers regarding refill renewals, therapeutic substitutions, and any needed clarification.• Transferred prescriptions between various pharmacy settings and accepted phoned-in prescriptions.• Reconstituted powdered medications into proper dosage forms and compounded suspensions, solutions, and topical preparations.• Counseled patients on OTC products, proper medication use, and relevant side effects.
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Pharmacy Technician
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Jan 2014 - Dec 2016
• Promoted adherence through outreach calls and texts, ScriptSync, and ReadyFill enrollment. • Managed inventory through cycle counts and daily ordering.• Communicated with insurance companies about rejected claims, prior authorizations, limitations, and overrides.
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Sales Associate
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Jul 2013 - Jan 2014
• Operated cash registers and the photo center and processed money orders• Assisted customers in locating products in the store.• Restocked inventory and organized shelves and sales signs.
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Rutgers University
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United States
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Higher Education
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700 & Above Employee
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Institutional Review Board Co-Investigator
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Jul 2019 - Aug 2019
• Acted as an Investigational Review Board co-investigator and teaching assistant, developing and assessing a student peer-led curriculum for pre-pharmacy students in the Summer Health Professions Education Program.• Analyzed the results of surveys, given to students before and after completion of the curriculum, into a Midyear research poster. • Acted as an Investigational Review Board co-investigator and teaching assistant, developing and assessing a student peer-led curriculum for pre-pharmacy students in the Summer Health Professions Education Program.• Analyzed the results of surveys, given to students before and after completion of the curriculum, into a Midyear research poster.
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Education
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2014 - 2020
Rutgers University
Doctor of Pharmacy (Pharm.D.) -
2011 - 2014
Central Bucks HS-South
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