VP, Regulatory & Scientific Affairs

Eversana

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Company Description

At EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 7,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! 

Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. 

Job Description

THE POSITION:

The VP will be responsible for the strategic and operational aspects of Regulatory affairs. They will support business development activities (pitch, fee proposal) and manage client deliverables, contractor work and related revenue and expense budgets. The position includes client engagement and oversight for deliverables which include the development and submission of Clinical Trial applications, New Drug Submissions and Supplemental New Drug Submissions as well as Public Release of Clinical Trial Submissions to Health Canada.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

We task our employees with delivering excellent business results through the efforts of their teams. These results are achieved by:

  • Overseeing the regulatory strategy and Health Canada submissions for EVERSANA clients
  • Setting clear goals in terms of direction, effective plans and measurable outcomes for work that is produced internally and externally
  • Ensuring the appropriate talent is recruited or contracted and onboarding is effective, and that all employees and contractors adhere to our cultural beliefs
  • Ensuring work is accomplished effectively by managing performance, work processes and other resources
  • Developing people and a talent pipeline to fill future business needs
  • Development of new customer projects that generate additional Regulatory consulting work as well as developing existing customer relationships leading to additional revenue, profit, and referrals
  • Planning, organizing and coordinating input into proposals, manages quotes for contractors/internal team to ensure target profitability
  • Ensuring effective communication within the team
  • Collaborating with internal departments to deliver on shared projects, e.g. PRCI projects
  • All other duties as assigned

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

PEOPLE LEADER (of Employees and Contractors)

People leaders must possess both the skills to effectively accomplish these tasks and the emotional intelligence to do so in alignment with our cultural values. In addition to the critical management and leadership tasks listed above, this role also includes the following unique responsibilities:

  • Responsible for identifying and allocating resources to effectively deliver on service requirements.
  • Ensure external partners are efficiently onboarded in such a way that meets all our compliance and administrative requirements.
  • Stay abreast of workload and augment with additional resources as needed.
  • Review performance relative to objectives and provide feedback; authorize and communicate fee changes.
  • Facilitates staff development plans and coordinates with project staffing to ensure that staff is utilized completely and appropriately
  • Provides leadership, coaching, mentoring, feedback and role modeling to managers and extended staff to ensure quality and accuracy of services as well as achievement of key metrics
  • As necessary, develop business case to bring this resource in-house, either the individual or firm, or alternatively to recommend the hire and build an internal team.

EXPECTIONS OF THE JOB:

Engage in business development activities to ensure the appropriate subcontractor experts are available to participate in proposal development and delivery. Develop cost-effective quotes based on proposed SOWs from contractors and time-on-project for employees for these proposals. Ensure service delivery that meets the needs of our clients. Create business case for any additional internal hiring to build capacity. Participate in EVERSANA brand and network building with local trade associations and conferences.

  • Travel (10%)
  • Hours: Monday to Friday (37.5 hours per week)

The above list reflects the general details necessary to describe the expectations of the position and shall not be construed as the only expectations that may be assigned for the position.

An individual in this position must be able to successfully perform the expectations listed above.

Qualifications

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

  • Education (Masters level required)
  • Experience and/or Training (20+ years in various pharmaceutical roles in Canada)
  • Licenses/Certificates (NA)
  • Technology/Equipment (computer literacy including oversight of eCTD and PRCI publishing)
  • Client-focused approach to work
  • Excellent interpersonal and intercultural communication skills, both written and verbal
  • Teamwork and collaboration
  • Critical thinking and problem-solving skills
  • Strategic business thinking
  • Consulting skills
  • Project management knowledge

PREFERRED QUALIFICATIONS:

  • Education (MSC, MBA, MBiotec)
  • Experience and/or Training (20+ years in the Canadian industry including leadership roles)

PHYSICAL/MENTAL DEMANDS AND WORKING ENVIRONMENT:

The physical and mental requirements along with the work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this position.

Office: While performing the essential functions of this job the employee is frequently required to reach, grasp, stand and/or sit for long periods of time (up to 90% of the shift), walk, talk and hear; occasionally required to lift and/or move up to 25 pounds. The noise level in the work environment is usually moderately quiet, with frequent interruptions and multiple demands. Currently work-from-home is available with attendance expected at team meetings in either Toronto or Burlington at the EVERSANA offices.

Additional Information

OUR CULTURAL BELIEFS:

Patient Minded I act with the patient’s best interest in mind.

Client Delight I own every client experience and its impact on results.

Take Action I am empowered and empower others to act now.

Grow Talent I own my development and invest in the development of others. 

Win Together I passionately connect with anyone, anywhere, anytime to achieve results.

Communication Matters I speak up to create transparent, thoughtful and timely dialogue.

Embrace Diversity I create an environment of awareness and respect.

Always Innovate I am bold and creative in everything I do.

EVERSANA is an equal opportunity employer which values diversity in the workplace and encourages applications from all qualified applicants. If you require an accommodation to participate in the recruitment and selection process please contract, [email protected].

For details on our AODA Accessibility Policy, please visit https://www.eversana.com/legal/canadian-accessibility-statement/

All your information will be kept confidential according to EEO guidelines.

From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone’s responsibility.

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