- Leads/represents PS on multiple cross-divisional governance and development teams while providing strategy and accountability for PS deliverables.
- Provides strategic scientific leadership and program management for multiple global PS development teams
- Identifies and communicates project or program risks and provides risk response strategies in a timely manner to appropriate stakeholders and PS management
- Lead/participate as functional expert in divisional and cross-divisional initiatives
- Leads the preparation of the PS sections of global regulatory submissions (e.g. CTAs and commercial applications) and PS responses to regulatory agencies; represents PS at meetings with regulatory agencies, as necessary.
- Manages PS development activities performed by external partners and companies to ensure project deliverables are being met; reviews contracts and invoices as necessary.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education / Experience
BS + 16 years; MS + 12 years; Pharma D + 11 years; PhD + 10 years
- Must have the maturity to utilize scientific and technical knowledge to provide unique business solutions.
- Experience must be in a scientific discipline with expert knowledge of pharmaceutical development, including an understanding of current laboratory techniques, instrumentation, problem solving techniques, process engineering and manufacturing development, and statistics used in experimental work.
- Must demonstrate knowledge of several allied fields such as chemical engineering, analytical/organic/physical chemistry, process engineering, pharmaceutics, quality assurance and/or regulatory affairs. Fundamental understanding in DMPK, Pharmacology and Toxicology.
- Extensive knowledge of current Good Manufacturing Practices (cGMP), ICH Guidelines, other pertinent national regulations, compendial requirements and communicating with regulatory agencies.
- Must have experience in global regulatory submission requirements and processes.
Program Management Skills/Competencies
Proficient in the application of project management knowledge, skills, tools (e.g. Microsoft Project), and techniques for complex multidisciplinary programs and initiatives.
- Leadership - develops and uses knowledge and interpersonal skills to influence and guide internal and external stakeholders towards the accomplishment of program and cross-divisional goals and objectives; adapts well to varied team dynamics and manages others team members in a respectful manner.
- Risk Management ability to identify/mitigate technical, budgetary, and schedule risks to multiple programs and propose appropriate risk response strategies. Ability to identify gaps in PS technology/trends and influence change/improvements to affected areas/processes.
- Communication ability to expresses one s self clearly and concisely to key stakeholders and functional management; documents issues and/or concerns concisely and comprehensively; adjusts style, language and/or terminology appropriate for the audience. Can represent PS viewpoint at divisional level.
- Resource Management Ability to anticipate and manage internal and external resource needs (people, information, technologies, time, and capital).
- PMP certification is preferred
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