Compliance jobs in Canada

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PURPOSE:

The Medical Lead develops the medical plan 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. You will report to the Medical Director of Rare Diseases.

KEY JOB ACCOUNTABILITIES:

• Support the Therapeutic Area Medical Director in developing therapeutic area strategies and ensuring understanding between the Medical Plan, Brand Plan, and broader medical goals.
• Implement the Medical Plan.
• Work with internal Takeda partners (Government Affairs, Marketing, Sales, and Global Medical Affairs) to align medical and scientific projects.
• Assure fiscal accountability of tactics according to the Medical Director.
• Oversee the generation, review, and communication of medical and scientific information according to Medical strategies, including responsibility for the following activities:
  • 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 compliant with Takeda standards, SOPs, and policies.
• Establish and maintain relationships with national opinion leaders in therapeutic area of expertise.
• Ensure the provision of accurate, compliant scientific data and expertise to external team members, 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 latest trends and developments that may improve business direction and provide summaries or critical assessments.

COMPETENCIES:

• Understanding of the pharmaceutical industry, product development, lifecycle, and commercialization processes, including important functions such as R&D, Regulatory, and Medical Affairs.
• Experience with 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 improving the area.
• Medical competence to understand the disease area landscape, contribute to the patient journey, and define product difference and value.
• Knowledge of important 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 multiple disease states.
• Analyze scientific results and present complex scientific/medical information to both scientific and lay audiences.
• Experience developing and operationalizing strategies and tactical plans.
• Develop a range of professionals within the therapeutic area.

Additional Competencies:

• Expertise in matrix project leadership and operational project management and simultaneously facilitating collaboration.
• Financial skills to forecast and manage a budget, and to understand the business possible effects of decisions and external factors.
• Excellent strategic thinking skills and strategic problem-solving ability, including driving to appropriate solutions.
• Manage senior partners and navigate conflict diplomatically.
• Vendor oversight experience.

Digital competencies

• Lead by example through intentional skill development, experimentation and encouraging a culture of digital curiosity.
• Experience working with colleagues in virtual or remote settings, using digital collaboration tools, incl. MS Teams.
• Proficiency in applying digital tools, platforms, Artificial Intelligence (AI) and other technologies (including Microsoft Office suite) to communicate with impact and perform tasks.
• Understanding of cybersecurity threats and best practices to protect sensitive information and systems.
• Prior experience driving digital transformation projects, showcasing technology improvement and integration with daily work practices.

EDUCATION, LICENSES/CERTIFICATIONS, EXPERIENCE:

• Advanced degree (MD, PharmD, PhD) in a related field, such as Health Sciences, is required.
• Consideration will be given to candidates with relevant pharmaceutical industry experience, and clinical work, research, or academic endeavors.
• Minimum of 5+ years of experience in the pharmaceutical industry and clinical/scientific experience, or equivalent combination with demonstrated leadership responsibilities within Medical/Scientific Affairs.
• Experience in the therapeutic area.
• Bilingual (English/French)

TRAVEL REQUIREMENTS:

• This is a head-office-based position in Toronto, Canada.
• Willingness to travel to multiple meetings or client sites, including overnight trips. Some international travel may be required.

Takeda Canada encourages applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial accessibility legislation, please advise us if you need accommodation in order to participate in the recruitment process. Any information you provide relating to accommodation will be addressed confidentially.