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Senior Manager, Regulatory Intelligence and Submissions

3 months ago

Western Springs, United States ProPharma Group Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world's largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.

The Senior Pharmacovigilance Manager, Regulatory Intelligence (RI) & Submissions position is responsible for maintaining and growing the RI repository and global submission capability in support of the Pharmacovigilance service line. The Senior Manager acts as a strategic business partner towards key accounts and their primary focus is on the RI & Submissions teams both from the customer as well as from the employee experience.

Essential Functions:

Developing and managing RI and Submissions policy:

  • Drives the long-term vision, strategic targets, and operational goals for the RI and Submissions teams.
  • Contributes to the PV sales goals by participation in the proposal process regarding RI & Submissions activities as needed and maintaining industry awareness of RI & Submissions task requirements and trends.
  • Participates in internal and external forms of consultation, dissemination of the vision, objectives, and philosophy of the organization and functions as an authority on the RI and submissions areas of expertise.
  • Regularly informs management regarding issues, progress, and developments within the RI and Submissions groups.
Directing the teams:
  • Manages direct reports including 1:1 meetings, performance reviews, frequent coaching, and redirection of activities as needed.
  • Oversees the RI and Submissions team's resourcing needs including evaluation of future needs, participation in the recruitment process, and interviewing candidates for potential hire.
  • Coaches and guides colleagues, act as a role model, and provide real time feedback to foster growth in employees.
  • Oversees the cohesion between various activities within the RI and Submissions groups and overall PV business to improve efficiency, effectiveness, and quality.
  • Identifies problems, risks, and bottlenecks in work processes and drive change to resolution while mitigating client, regulatory, and company risks.
Performing relations management:
  • Conducts negotiations for complex and sensitive projects with at large clients or commercial partners and manages as such within the RI and Submissions groups.
  • Identifies changes needed to improve client satisfaction and provide oversight of quality and compliance.
  • Responsible for the transition of departmental activities following company acquisitions.
  • Acts as the global escalation point for critical issues. When necessary, directly oversees the activities as listed:
    • Coordination of regulatory submission team.
    • Creation and maintenance of RI tool.
    • Dissemination of Regulatory Intelligence information and training as needed for staff.
  • Quality investigations for RI and Submissions related activities.
  • Other duties as assigned.
Necessary Skills and Abilities:
  • Expert knowledge of global pharmacovigilance practices and regulatory requirements.
  • Strong verbal and written skills.
  • Ability to communicate effectively within the PV organization and cross-functionally and with all levels.
  • Outstanding analytical and strategic thinking skills.
  • Proficient organization, prioritization, and project management skills
  • Self-motivated and ability to motivate others.


Educational Requirements:

Minimum college degree required; MSc/PhD preferred.

Experience Requirements:

Minimum of 5 years' experience in clinical and/or post-marketing pharmacovigilance.

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#REMOTE

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***