Scientific Integrator - Senior Scientist

• Single point of contact for AD and the analytical expert in the commercial product teams.​
•  Oversees and manages the project strategy for AD and translates project strategy needs into AD functional
  tasks, deliverables, and timelines.
• Leading analytical commercial product teams.
• Assures appropriate analytical understanding/knowledge and scientific rigor for assigned commercial
  projects leveraging relevant science and risk-based approaches
• Connects in a seamless manner as required to other relevant analytical/functions/stakeholders to ensure
  commercial product challenges are addressed
• Responsible for specification setting/justification and management.
• Escalates potential issues to management and serves as analytical strategist and coordinator in crisis
  management situations.
• Ensures management of change control for analytical deliverables.
• Uses the described processes to develop and maintain a quality product based on the actual guidelines and
  standard operating procedures
• Aligns the analytical technical content across each section of the commercial dossiers. Answer relevant
  questions and support Health Authority inspections and customer audits as necessary.
• Responsible for the analytical project budget.
• As requested, develop strategies, implement activities to achieve departmental goals; contribute to improve
  business/work processes across the organization
• Act as a mentor to fewer experience colleagues

Skills Preferred

• An advanced scientific degree or Ph.D. degree in Chemistry, Pharmacy, Biochemistry is preferred.
• Strong analytical scientific and project management skill
• Knowledge of global regulatory requirements and guidelines applicable to pharmaceuticals (small
  molecules), with the ability to apply cGMP regulations, ICH guidelines, and other FDA guidelines to all
  aspects of the position.
• Experience in leading cross-functional project teams and influencing members. Demonstrated record of
  customer focus and being results-driven.
• Ability to work independently and effectively on complex issues; handle multiple tasks, respect
  commitments, as well as experience in process improvement initiatives, process excellence, and people
  coaching in a high matrix organization.
• Ability to prioritize and balance workload.
• Knowledge of the English Language, both written and spoken is essential
• Utilizes computer software packages in order to perform the duties of the job.