Director I&D Operational Excellence

Director Innovation & Development Operational Excellence

for its global Pharma Division Headquarter based in Allschwil- Basel.

Primary Job Function:

Director, I&D Operational Excellence leads the provision of I&D operations to internal cross-functional stakeholders: Clinical Development, Medical Affairs, Regulatory Affairs, Product Development, Portfolio and Project Management, Pharmacovigilance and I&D Controller.

Establishes and leads a team to implement agile, streamlined, end to end and high quality I&D governance, processes and systems (for in scope departments), ensuring compliance with respective industry standards, applicable laws and regulations and quality requirements.  Drives continuous improvement across applicable I&D processes. 

Core Job Responsibilities:

• Establishes and leads the EPD I&D Operational Excellence department, including all activities at any level in EPD undertaken by the department personnel; establishes strategic planning and direction for the department.

• Leads the ownership of I&D functional related process and procedures within the Quality System and their associated training and implementation. Works in close partnership with I&D QA.

• Establishes and drive I&D Governance processes through self-assessment, regular monitoring, KPIs and process improvement initiatives to ensure compliance of EPD I&D personnel to quality system and other company policies and procedural requirements.

• Leads development and maintenance of systems and tools to conduct Medical Operational responsibilities such as, KOL Management System, Medical Information System, Promotional Material Review system and other systems and databases as required.

• Leads provision of services regarding external HCP and KOL contracting and maintains quality and compliance standards in accordance with applicable laws, regulations, and Abbott OEC / financial policies.

• Leads provision of services for Medical Affairs including promotional material review, responding to medical enquiries; review of global promotional materials, provision of medical writing services for PV and Regulatory documents, representation on relevant governing bodies (labelling sub teams, digital review board etc).

• Supports tracking of individual EPD I&D department budgets and implement tracking and tools to provide information to EPD I&D functional leaders to help manage their assigned department budgets according to plan.

• Attracts, maintains and develops talent to ensure the highest value to the business. Creating an environment to empower the people. Mentors managers in relevant functional skills, business knowledge, and management skills. Develops future leaders with intrapreneurial mind-set.

Minimum Education:

• Bachelors and/ or Masters degree preferred.

Minimum Experience/Training Required:

• Minimum 15 years of experience in pharmaceutical industry in R&D, medical, clinical or pharmacovigilance fields with minimum 5 years of solid-line people management experience.

• Ability to work in a complex cross-cultural environment, with stakeholders all around the world

• Ability to make effective decisions based on good science and data in compliance with regulatory requirements and risk assessments

• Excellent knowledge of R&D, medical affairs, clinical development, pharmacovigilance and regulatory requirements of pharmaceutical products

• Advanced project management skills

• Ability to fully operate independently, with recognition of when to consult senior management

• Excellent English language skills, particularly in written form

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf .

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