Alkesh Lokhande

About Alkesh Lokhande

14+ years of core experience in Regulatory/medical writing including regulatory submissions and drug safety surveillance (clinical and post-marketing). Led various regulatory reports (Investigator’s Brochure [IB], Clinical Study protocols, Clinical Study Report, New drug application [NDA], Abbreviated New Drug Application [ANDA], Biologics License Application [BLA] and Briefing Packages). Lead writer for eCTD module 2.7.4, 2.5 and 5 for US-FDA & EMA submissions. Risk Management/Minimization Plans (RMPs); Development RMP, Core-RMP and led RMPs for marketing authorization applications (MAA) for US-FDA and EMA. Health Regulatory Authority responses on received queries and Benefit risk evaluation. Periodic safety aggregate report writing and review: Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Event Reports (PADERs). Signal detection/management- Qualitative/Quantitative (Empirica, EVDAS and FAERS, RAVE, REACT, SENTRI).

Experience

1. Senior Scientific Writer (Oncology)

   百时美施贵宝

   Jul 2024 — Present · Hyderabad, IN

   Author complex clinical documents [eg, Investigator\'s Brochures (IB), Protocols, Phase 2/3 Clinical Study Reports (CSR), briefing documents, Common Technical Document (CTD) summary documents, responses to Health Authority queries] for timely submission to health authorities worldwide according to: o good documentation principles (organization, clarity, scientific standards) o consistency between text and tabular presentations or graphical displays o in compliance with BMS documentation standards and worldwide regulatory requirements• Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.• Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.• Participate in document prototyping sessions, including document flow, logic, and consistency for assigned project prototypes, and maintain document prototypes and shells. • Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure: o optimal communication between authoring team and development team members o coordination and efficient use of messages between internal development plans, IND and Marketing Authorization documentation o timely completion and high quality of assigned documents• Review and edit documents as required.• Serve as a liaison for external documentation support (when required), prepares specifications for the work, and ensures maintenance of good documentation principles as well as BMS documentation standards.• Lead and influence a diverse group of authors of regulatory documents from a variety of disciplines without a reporting relationship.

Education

• SVKM's Narsee Monjee Institute of Management Studies (NMIMS)

  M.Pharm, Clinical Pharmacy

• Manipal Academy of Higher Education

  Doctor of Philosophy (Ph.D.), Pharmacovigilance, Drug Safety surveillance, PSUR preparation and submission

  2012 — 2016

• Manipal Academy of Higher Education

  Ceriticate course in Biostatistics, Epidemiology and Research Methodology, Statistics

  2013 — 2013

Skills

• CRO
• Clinical Research
• Clinical Pharmacology
• Sas for Statistical Analysis
• Regulatory Affairs
• Lifesciences
• Clinical Trials
• Drug Delivery
• Pharmacokinetics
• Good Clinical Practice (Gcp)
• Pharmacy
• Meddra
• Spss Software Package for Statistical Analysis
• Pharmacovigilance
• Pharmaceutical Industry
• Drug Safety
• Pharmaceutical Research
• Pharmaceutics
• Drug Discovery
• Ich-Gcp
• Pharmacology
• Ctms
• Life Sciences
• Drug Development
• Gcp
• Regulatory Submissions
• Clinical Development
• Medical Writing
• Arisg