Regulatory Affairs jobs in Canada

PURPOSE:

The Medical Lead is responsible fordeveloping and executing the medical plan in alignment with the Medical Director for an assigned program(s) within a Therapeutic Area team in Takeda Canada. The Medical Lead provides clinical/medical expertise, ensures medical excellence and compliance with applicable policies, and contributes strategic insight and tactical execution of Medical plans.

This role requires a strategic thinker who can inspire others, focus on key priorities, and elevate organizational capabilities in line with Takeda's Leadership Behaviors.

KEY JOB ACCOUNTABILITIES:

• Support the Therapeutic Area Medical Director in developing and implementing therapeutic area strategies and ensuring alignment between the Medical Plan, Brand Plan, and broader medical objectives.

• Strategic implementation of the Medical Plan.

• Work collaboratively with internal Takeda stakeholders (Government Affairs, Marketing, Sales, Global Medical Affairs) to align strategic medical and scientific initiatives.

• Assure fiscal accountability of tactics in alignment with the Medical Director.

• Oversee the generation, review, and communication of medical and scientific information in alignment with Medical strategies, including responsibility for the following activities as needed:

• Medical Information and Publications support.

• Medical Review of promotional pieces.

• Medical Congress support.

• Grant and Donation review.

• Ad hoc support for the Global Enterprise Engagement Model.

• Ad hoc support for Investigator-initiated Research.

• Direct the development of scientific education/other learning activities, ensuring accurate interpretation and communication of scientific data related to Takeda products.

• Ensure that all clinical evidence, promotional, and non-promotional materials are scientifically sound and fully compliant with Takeda standards, SOPs, and policies.

• Establish and maintain strong relationships with national opinion leaders in therapeutic area of expertise.

• Ensure the provision of accurate, compliant scientific data and expertise to external stakeholders, including government bodies, institutions, healthcare professionals, and networks.

• Represent Takeda’s scientific position through appropriate interpretation and communication of clinical evidence and product data.

• Maintain awareness of external developments, product pipelines, and scientific literature relevant to the therapeutic area.

• Keep leadership informed of emerging trends and developments that may impact business direction and provide summaries or critical assessments as needed.

COMPETENCIES:

Occupational Knowledge and Skills

• Deep understanding of the pharmaceutical industry, product development, lifecycle, and commercialization processes, including key functions such as R&D, Regulatory, and Medical Affairs.

• Thorough understanding of legal, compliance, and regulatory guidelines related to medical affairs in the pharmaceutical industry.

• Knowledge of the Health Canada policies and other federal and provincial policies impacting the area.

• Medical competence to understand the disease area landscape, contribute to the patient journey, and define product differentiation and value.

• Knowledge of pertinent external treatment guidelines and current standards of practice for relevant disease areas.

• Therapeutic knowledge, with a preference for prior experience in the therapeutic area, demonstrated ability to quickly gain in-depth understanding of various disease states.

• Ability to analyze and interpret scientific results and present complex scientific/medical information to both scientific and lay audiences.

• Proven ability to develop and operationalize strategies and tactical plans.

• Strong demonstrated leadership skills to manage and develop a range of professionals within the therapeutic area.

Additional Competencies:

• Proven expertise in matrix project leadership and operational project management, with the ability to manage multiple complex tasks simultaneously and facilitate cross-functional collaboration effectively.

• Demonstrated ability to think strategically, solve complex problems, and apply strong business acumen.

• Financial skills to forecast and manage a budget, and to understand the business implications of decisions and external factors.

• Excellent strategic thinking skills and proven strategic problem-solving ability, including driving to appropriate solutions.

• Strong verbal and written communication skills, including scientific writing, presenting, influencing, and negotiating.

• Influencing without authority, managing senior stakeholders and navigating ambiguity and conflict diplomatically.

• Vendor oversight experience.

Digital Competencies:

• Dedication to leading by example through intentional skill development, experimentation and fostering a culture of digital curiosity within the organization.

• Experience working effectively with colleagues in virtual or remote settings, utilizing digital collaboration tools, incl. MS Teams.

• Proficiency in leveraging digital tools, platforms, Artificial Intelligence (AI)and other technologies (including Microsoft Office suite) to communicate with impact and perform tasks efficiently and effectively.

• Understanding of cybersecurity threats and best practices to protect sensitive information and systems.

• Prior experience in driving digital transformation initiatives, showcasing a strategic mindset towards technology innovation and integration with daily work practices.

EDUCATION, LICENSES/CERTIFICATIONS, EXPERIENCE:

• Advanced degree (MD, PharmD, PhD)preferred.

• Consideration will be given to candidates with relevant pharmaceutical industry experience, and/or clinical work, research, or academic endeavors.

• Minimum of 5+years of experience in the pharmaceutical industry and/or relevant clinical/scientific experience, or equivalent combination with demonstrated leadership responsibilities within Medical/Scientific Affairs.

• Experience in the therapeutic area is preferred.

• Bilingual (English/French) is a strong asset

TRAVEL REQUIREMENTS:

• This is a head-office based position in Toronto, Canada.

• Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.