Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose: Oversees operational excellence of the department by providing strategic leadership, oversight, guidance, and/or technical expertise to direct reports who support the department in one or more specialty areas. Ensures the operational success of assigned specialty areas across the department. Actively drives goals / initiatives and partners with the Senior Leadership team to help achieve operational and financial success. Identifies and develops business opportunities involving department projects and opportunities for the organization. Works collaboratively with multiple stakeholders within the organization on specific enterprise-wide initiatives to deliver business objectives. Promotes a culture of accountability and continuous process improvement.
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Essential Functions:
- Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, behavioral and technical coaching and mentoring, employee counseling, and separations.
- Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime.
- Promotes all aspects of the organization's Equal Employment Opportunity policy and Affirmative Action Plan. Assures department adherence to good ethical and regulatory standards.
- Creatively provides leadership, oversight and/or technical expertise to business critical supporting structures.
- Effectively staffs uniquely skilled resource for innovative supporting structures, and conducts performance management and development of staff spanning multiple functional areas.
- Ensures the infrastructure, systems, processes and policies to effectively support PV efficiently developed and executed.
- Leads and assists in business development activities to obtain additional contracts by writing and reviewing proposals, presenting business proposals and capabilities to potential clients. actively seeks client relationships and supervises strategic sell initiatives. Represents the organization as an accountable leader during external FSP governance meetings.
- Manages, coordinates and oversees activities within assigned sub-department, including resourcing, budget management (annual and long range forecasts), training and/or process improvement initiatives to ensure excellence in performance.
- Collaborates with senior leadership team in developing, authorizing, and promoting the implementation of corporate policies, interpersonal policies and/or strategic business plans, providing objective assessment of activities, including opportunities, risk assessment and mitigation. Liaises with internal cross functional stakeholders, teams and clients.
Qualifications:
Education and Experience:
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 15+ years).
- 8+ years of management responsibility
- Prior success leading and mentoring a highly experienced PV technical team, fostering a culture of excellence and continuous improvement
- Oversee the management and maintenance of PV systems and processes to ensure compliance with regulatory requirements.
- Experience in developing and implementing a strategic plan to preserve and grow the PV business
- Drive the adoption of new technologies and innovative solutions to enhance PV processes and systems.
- Experience in assessing and managing risks and challenges associated with PV integration during mergers and acquisitions
- Communicate effectively with senior leadership, providing updates on PV technical operations, strategic initiatives, and industry developments.
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Highly effective influencing in matrix environments within and outside of the department
- Expert knowledge of regulatory considerations governing operational areas of accountability and inclusive of GCPs, FDA/ICH guidelines, experience with and other established national and international regulatory authorities
- Detailed understanding of the drug development lifecycle spanning clinical trial and post market authorization
- Extensive knowledge of department systems
- Expert knowledge of strategic planning, budgeting, forecasting, resourcing and fiscal management
- Demonstrated ability to negotiate and effectively influence executives and other stakeholders
- Ability to tactfully supervise, delegate, coach/mentor and objectively evaluate staff
- Change management experience with demonstration of building highly motivated and integrated teams that deliver high quality of work within budgeted hours and timelines
- Extensive ability to analyze industry standards, competitive solutions and resolve complex cross functional issues and mitigate risk
- Actively partners with Business Development and other departments/divisions to ensure successful outcome of contract/regulatory deliverables
- Through understanding of business practices and an in-depth understanding of organizational SOPs and operational/financial practices
- Ability to present services to sponsors and prepare effective proposals for Pharmacovigilance and Regulatory Affairs activities which include the specific value proposition for the client/sponsor
Management Role:
Manager role with significantly larger management scope (e.g. global or regional responsibilities or multiple departments) OR mastery of manager skills and responsibilities as demonstrated by consistent, multi-year successful performance. In some instances may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees