Summary
Overview
Work History
Education
Skills
Websites
Certification
Hobbies and Interests
Volunteer Experience
Timeline
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Nehal Kawa

Summary

Results-driven Project & Program Management Professional with over 10 years of experience leading nearly 70 diverse projects. Demonstrates expertise in cross-functional collaboration and prioritization, ensuring alignment with stakeholders to meet strategic objectives. Proven ability to deliver projects on time and within budget while effectively addressing business needs. Committed to continuous learning and adept at adapting to new environments, resulting in optimal project outcomes.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Program Management Lead

Imvax
, USA
03.2022 - 04.2025
  • Align, collaborate, oversee execution of Phase 1, Phase 2, Phase 3 activities for tumor-derived immunotherapy portfolio with 10+ internal cross functional groups including Medical Affairs, Clinical Development & Operations, Regulatory, R&D, Manufacturing, Quality, Process Development, Supply Chain, Device Management, and external alliance groups
  • Develop a detailed project plan that is aligned with the overall program strategy and manage all aspects of scope, resources, and timeline for the portfolio of projects
  • Collaborate with the team/functional leaders to track the key operational aspects of the program(s), including monitoring key deliverables, decision points, demand planning, and critical path activities to drive delivery of project objectives
  • Ensure timely execution of critical tasks, milestones, and deadlines
  • Follow up with teams to continuously update the plan and prioritize activities as needed for the successful implementation of the project
  • Develop and provide consistent project tracking and project reporting to Management and project teams
  • Accountable for integrated project plan management, including maintenance of up-to-date project timelines and timeline scenario planning
  • Create and manage all integrated meeting logistics including the creation of clear and concise meeting minutes that are shared as appropriate to align all functional representatives of decisions and actions agreed upon by the team
  • Dotted-line accountability to manage a team of project managers (PMs) that work alongside cross-functional teams to meet project objectives and deadlines working closely with department heads and their PM resources
  • Leverage established portfolio and program management tools to track program execution, milestones, risks, and long-range planning to ensure appropriate communication to team members and management
  • Partner with Head of R&D to support and ensure timely and efficient completion of assays, laboratory activities for Regulatory submissions
  • Partner with the Head of CMC and external alliances to facilitate the management of risk by scheduling meetings with the CMC teams as appropriate
  • Responsible for gaps analysis and risks management for qualification and validation runs, Phase 1, IND submission, Phase 2, and Phase 3 readiness
  • Support business operations for Head of Clinical Development and Medical Affairs, Clinical Operations, and Regulatory Affairs
  • Support the Head of CDMA to manage the relationship with our outsourced regulatory group, including the development and submission of key regulatory documents (IND amendments, annual DSUR update, and annual IB update, among others)
  • Align and collaborate with the Safety & PV Lead and the Clinical Scientist to develop and update the Safety & PV dashboard
  • Collaborate and align with the MSL team to develop and update the KOL engagement dashboard
  • Lead program management activities to support key corporate initiatives such as planning for the annual conference of the Society for Neuro-Oncology (SNO)
  • Support and oversee Patient Advocacy activities, including 5K and other events
  • Interact with the Executive Team and prepare documentation for important meetings internally and with the board
  • Environment: MS Project, Office Timeline Pro+, PleaseReview, Microsoft Teams, SharePoint, Adobe Acrobat Pro, MS Office 2013, Zen QMS

Senior Project Manager

Radius Health
, USA
03.2021 - 02.2022
  • Oversee project management activities and lifecycle of multiple projects for specialty drug therapy
  • Manage global projects (US NDA, sNDA, EU MAA, UK MAA, Canada NDS) to deliver key milestones and activities, directly reported to Chief Business Officer
  • Collaboration with cross functional team meetings (Regulatory, Clinical Development and Operations, Non-clinical, Quality Assurance, Manufacturing, Biostatistics, Pharmacovigilance, Medical Affairs, Vendors – Medical writers)
  • Co-ordinate and plan activities with broad cross functional teams (Commercial, Legal, Finance, HR, IT)
  • Provide and manage regular program-wide dashboards for each development program to Executive leadership team
  • Maintain and control the project schedule, track progress made on tasks
  • Maintain and organize all files related to a project (e.g., timelines, minutes, related documents)
  • Identify activities on the critical path, critical issues, overlap and communicate the status of the project to appropriate stakeholders
  • Environment: MS Project, Office Timeline Pro+, Smartsheet, Veeva RIM (Author, reviewer, approver); Veeva CDOCS, Microsoft Teams, SharePoint, Adobe Acrobat Pro, MS Office 2013

Senior Regulatory Project Associate

Amgen
, USA
07.2019 - 02.2021
  • Support Global CMC RA team (biologics, biosimilars, small molecules, combination products) for project management of IND/CTA, NDA/BLA/MA, Variation submissions; support CMC document and project management of acquired products
  • Lead and supported regulatory projects - 4 INDs, 5 NDA, 2 BLA, 7 Post-approval variations filings, 9 Annual reports for INDs and NDAs in regions like USA, Europe, LATAM, Gulf, Russia
  • Independently manage review and approval of scientific documents (Modules 2 and 3 section of eCTD) with global leads
  • Develop submissions using FDA, MHRA, TGA, Canada and ICH guidelines/eCTD trackers
  • Execute several Response to Regulatory Agency Questions on tight timelines working with Subject Matter Experts
  • Coordinate requests for US/EU CPPs, GMP certificates/declarations for notarization/legalization activities
  • Develop timelines of regulatory submissions and leading preparation of documents
  • Train and mentor new hires in CMC regulatory processes and tasks
  • Author internal team process for identifying and correcting root causes to drive departmental and cross-departmental goals
  • Environment: Veeva RIM (Author, reviewer, approver), EPIC; Veeva CDOCS, Insight viewer, Trackwise, SharePoint, Adobe Acrobat Pro, MS Office 2013, LMS

Quality Management Intern

Alkermes
, USA
07.2018 - 09.2018
  • Prepare and manage US FDA Inspection readiness activities in collaboration with cross-functional teams, conduct mock inspection sessions, execute quality review activities to identify potential gaps for internal audits and external audits
  • Assist in conducting Global Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) audits, supporting drug development cycle (Phase 1, Phase 2, Phase 3)
  • Support US FDA Inspection Readiness for: GCP, GVP, and Risk Evaluation & Mitigation Strategy (REMS)
  • Deliver presentation on mock inspection for cross-functional SMEs: Drug Safety, Medical Affairs, Sales team
  • Draft using MS-Word, Adobe Acrobat Pro and review Audit documents (Audit Plan, Audit Responses, Audit Report, Audit Certificate) of GCP external vendors and CROs ensure quality and record completeness
  • Ensure SOPs and documents are updated, maintain good documentation practices
  • Analyze clinical quality requirements into high-level and low-level ICH guidelines, US FDA GCP guidance, BIMO
  • Environment: Veeva Vault (eTMF), SharePoint, Adobe Acrobat Pro, MS Access 2016, MS Office 2013, LMS

Project Management Intern

Focus Marketing
, USA
04.2018 - 06.2018
  • Liaison between client and marketing personnel
  • Assist Project Director in preparing project plans to increase sales for the client, improve customer relationships, and improve processes
  • Coordinate pre-fieldwork activities and assisted Project Director in creating, monitoring project timelines, scope, budget, quality, risk management plans using Agile methodologies, Gantt Chart, Network Diagram
  • Prepare and execute strategies to identify & solve the problems related to fieldwork activities
  • Monitor on-site fieldwork activities for effective implementation to enroll more customers
  • Develop dashboard communications regarding project planning & delivery performance across multiple stakeholders in collaboration with subject matter experts
  • Understand the business requirements, identified gaps in different processes and implemented process improvement
  • Environment: Agile Project Management, Windows 10, MAC OSX, MS-Project, MS-Office, Minitab, SharePoint, LMS

Project Executive

Ipca Laboratories Ltd
, India
05.2012 - 02.2017
  • Ensure execution of clinical research of safety and efficacy of the therapies, studies conducted on over 800 patients
  • Collaborate with the selected CRO to finalize the study specific task order, coordinated for proper execution
  • Perform quality check of reports generated from study system (CTMS)
  • Review study report to ensure correctness in compliance with ICH guidelines, SOPs and regulatory requirements
  • Conduct Requirements Analysis and GAP Analysis to ensure accuracy and quality
  • Create reports using MS-Excel and Pivot tables to do the calculations
  • Environment: CTMS, SQL, SPSS, MS Excel, MS Project, MS Visio, MS Office

Education

Master of Science - Project Management & Regulatory Affairs

Northeastern University
Boston, MA
05.2019

Post-Graduate - Management Studies

IES College and Research Centre
Mumbai, India
04.2015

Bachelors - Alternative Medicine

Smt. CMPH Medical College
Mumbai, India
04.2012

Skills

  • Project management
  • Regulatory compliance
  • Clinical development
  • Risk management
  • Cross-functional collaboration
  • Timeline management
  • Stakeholder engagement
  • Process improvement
  • Meeting facilitation
  • Project tracking
  • Team leadership
  • Effective communication
  • Problem solving
  • Strategic planning
  • Relationship management
  • Idea development and brainstorming
  • Negotiation and conflict resolution
  • Resource allocation
  • Adaptability and flexibility
  • Program review
  • Reliability
  • Decision-making
  • Documentation and reporting
  • Multitasking Abilities
  • Conflict resolution
  • Time management
  • Process optimization
  • Employee training
  • Managing operations and efficiency
  • Customer relationship management
  • Quality control
  • Change management
  • Project coordination
  • Verbal and written communication
  • Work Planning and Prioritization
  • Crisis management
  • Organizational skills
  • Professional demeanor
  • Goal setting
  • Innovation management
  • Project planning
  • Good judgment
  • Training and mentoring
  • Positive attitude

Certification

  • ICF Accredited Programs –Leadership & Executive Coach, Life Coach
  • Agile Project Management- PMI Registered Education Provider
  • Project Management Foundations- PMI Registered Education Provider
  • FDA eCTD Overview and Submission, CMC Perspective of the IND
  • How to Study and Market your Device

Hobbies and Interests

  • Yoga
  • Hiking
  • Coaching
  • Painting

Volunteer Experience

Volunteer, Hunterdon Art Museum, Clinton, NJ, Volunteer for art exhibits

Timeline

Program Management Lead

Imvax
03.2022 - 04.2025

Senior Project Manager

Radius Health
03.2021 - 02.2022

Senior Regulatory Project Associate

Amgen
07.2019 - 02.2021

Quality Management Intern

Alkermes
07.2018 - 09.2018

Project Management Intern

Focus Marketing
04.2018 - 06.2018

Project Executive

Ipca Laboratories Ltd
05.2012 - 02.2017

Master of Science - Project Management & Regulatory Affairs

Northeastern University

Post-Graduate - Management Studies

IES College and Research Centre

Bachelors - Alternative Medicine

Smt. CMPH Medical College

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Nehal Kawa