Summary
Overview
Work History
Education
Skills
Accomplishments
Websites
Awards
Affiliations
Certification
Interests
Timeline
Generic

Rose Romano

Vaughan,ON

Summary

Accomplished pharmaceutical industry professional with over 20 years of experience in medical education, medical affairs, and regulatory affairs across various therapeutic areas. Proven track record in developing and executing innovative medical education programs, implementing impactful KOL engagement strategies, and collaborating with diverse teams to drive success.

Overview

21
21
years of professional experience
1
1
Certification

Work History

Medical Communications Manager, Gastroenterology

Takeda Canada Inc.
04.2024 - Current

Develop and implement tailored medical education programs for inflammatory bowel disease (IBD) based on HCP needs assessments.

  • Collaborate with cross-functional partners (medical, compliance, commercial, PSP) to develop aligned strategies and lead of integrated brand team (IBT)
  • Organize national symposia and congress-related educational activities with medical and Key Opinion Leaders (KOLs).
  • Facilitate steering committees, faculty engagement, speaker coordination, field engagement with KOLs driving medical strategic vision.
  • Monitor and evaluate program outcomes to continuously improve educational offerings and enhance HCP engagement.
  • Review grants with compliance and lead discussions on committee.

National Medical Communications Manager, Neuroscience

Takeda Canada Inc.
04.2020 - 04.2024
  • Designed and launched comprehensive medical educational programs for ADHD and Binge-Eating Disorder (BED), leveraging innovative interactive formats which reached over 3000 HCPs in one year.
  • Built and maintained strong relationships with faculty, facilitating their involvement in program development and delivery for a national webinar series and an accredited program.
  • Managed four external vendor partnerships to execute national and regional learning programs adhering to timelines and budget.
  • Conducted regular feedback consultative sessions with HCPs to refine and adapt educational content to meet evolving needs.
  • Collaborated with medical and commercial teams to ensure learning programs supported broader strategic objectives.

Medical Science Liaison, IBD

Takeda Canada Inc.
04.2019 - 04.2020
  • Developed strategic regional medical plans for ON East and Atlantic territories, aligning with global publication plan.
  • Delivered 16 impactful post-congress presentations to KOLs, enhancing their understanding of complex medical concepts and treatment options.
  • Identified and cultivated three new speaker opportunities to expand the reach of educational initiatives.
  • Supported the development of two national and three advisory boards, ensuring alignment with regional strategies and enhancing stakeholder engagement.

Medical Manager / MSL, Oncology

Takeda Canada Inc.
03.2018 - 04.2019
  • Led National medical strategy for the solid tumors portfolio
  • Developed MSL medical strategy, plan of action, and metrics
  • Trained MSLs, developed slide decks and training materials
  • Supported medical information questions from the field
  • Led and provided guidance for national and regional advisory boards
  • Internal medical expert for cross-functional teams
  • Supported internal teams (e.g. sales, medical education, regulatory, market access) with medical expertise
  • Discussed top scientific data with KOLs from Ontario East

Senior Manager, Regulatory Affairs

Takeda Canada Inc.
02.2017 - 03.2018
  • Successfully developed and filed one New Drug Submission (NDS), six Level I (SNDSs), 26 Level II (NCs), and 49 Level III/IV submissions to support seven products (pharmaceuticals and biologics) in the therapeutic areas of: cardiovascular, metabolic, gastrointestinal diseases, and oncology in eCTD
  • Collaboratively worked with cross-functional SMEs to develop regulatory strategy and path forward with Health Canada for stem cell based therapy NDS
  • Provided input and review of all labelling, promotional and non-promotional materials
  • Regulatory lead and expert on brand team.

Project Manager, Regulatory Affairs

Takeda Canada Inc.
01.2011 - 02.2017
  • Led and managed Health Canada review, attained best label globally, and earlier approval of the NINLARO® NDS
  • Executed the dissemination of three Dear Healthcare Professional Letters
  • Effectively provided regulatory guidance in the filing of clinical trial applications (CTAs) for oncology and vaccine pipeline products.
  • Coordinated four pre-NDS meetings with Health Canada and managed post-meeting activities.

Project Manager, Regulatory Affairs

Wyeth Canada, a Pfizer Company
01.2006 - 01.2010

Regulatory Affairs Associate

Hoffmann La-Roche Ltd.
01.2005 - 12.2005

Regulatory and Quality Associate

Experchem Laboratories Inc.
01.2004 - 12.2004

Education

Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations

Seneca College At York University
Toronto, ON
10-2004

Honours Bachelor of Science - Biology, Minor in Psychology

McMaster University
Hamilton, ON
04-2003

Skills

  • Medical education program development and execution (accredited and non-accredited)
  • Skilled in cross-functional collaboration and relationship building with internal and external stakeholders
  • Strong communication and presentation skills
  • Strategic and tactical thinker
  • Congress symposium and advisory board planning
  • Effective leadership and mentoring abilities
  • Strong scientific acumen and proficient in analyzing medical concepts
  • Compliance with industry codes (IMC, PAAB, PV) and policies, global and local SOPs

Accomplishments

  • Earned certification as Continuing Professional Development (CPD) Program via CCPE
  • Executed impactful, high-quality medical education programs that engaged over 3000 HCPs in one year
  • Coordinated 4 speaker tours with top international KOLs
  • Filed and received Notices of Compliance (NOCs) for 5 New Drug Submissions (NDSs)with Health Canada
  • Earned certification as CCPE Accreditation for Sales
  • Earned Post-Graduate College Certificate in Pharmaceutical Regulatory Affairs and Quality Operations


Awards

  • President's Award - Regulatory Strategy for ALOGLIPTIN NDS, 2013
  • Aspire to Lead Award for DE&I leadership, 2021
  • Aspire to Lead Award for DE&I leadership, 2022


Affiliations

  • Council for Continuing Pharmaceutical Education (CCPE)
  • Healthcare Businesswomen's Association (HBA)
  • Women Leaders in Pharma (WLP)

Certification

  • Pharmaceutical Regulatory Affairs & Quality Operations (RAQC) Ontario Graduate Certificate, Seneca College - October 2004
  • CCPE Accreditation for Sales - Feb 2010
  • Continuing Professional Development (CPD) via CCPE - May 2025

Interests

  • Co-Lead of DE&I Council at Takeda Canada (2024-2025)
  • Wellness including yoga and meditation practice
  • Experiencing different cultures through travel and culinary cuisine

Timeline

Medical Communications Manager, Gastroenterology

Takeda Canada Inc.
04.2024 - Current

National Medical Communications Manager, Neuroscience

Takeda Canada Inc.
04.2020 - 04.2024

Medical Science Liaison, IBD

Takeda Canada Inc.
04.2019 - 04.2020

Medical Manager / MSL, Oncology

Takeda Canada Inc.
03.2018 - 04.2019

Senior Manager, Regulatory Affairs

Takeda Canada Inc.
02.2017 - 03.2018

Project Manager, Regulatory Affairs

Takeda Canada Inc.
01.2011 - 02.2017

Project Manager, Regulatory Affairs

Wyeth Canada, a Pfizer Company
01.2006 - 01.2010

Regulatory Affairs Associate

Hoffmann La-Roche Ltd.
01.2005 - 12.2005

Regulatory and Quality Associate

Experchem Laboratories Inc.
01.2004 - 12.2004

Graduate Certificate - Pharmaceutical Regulatory Affairs & Quality Operations

Seneca College At York University

Honours Bachelor of Science - Biology, Minor in Psychology

McMaster University
Rose Romano