Associate Director, Medical & Regulatory Operations Training & Procedures

Associate Director, Medical & Regulatory Operations Training & Procedures

 

Cephalon is a place to think big.  It’s a work environment that challenges sharp minds, values an eye for opportunity and satisfies the motivation to make a positive impact.  The success of the company today reflects a collective ability to spot unexpected opportunities and the courage to waste no time in seizing them.  It’s a place where confidence is valued, independence is encouraged and agility is rewarded.

 

Position Summary

 

The associate director is responsible to upgrade operating procedures, deliver training for implementation, and to confirm performance and outcomes. Support of activities to improve, develop, implement and maintain Medical & Regulatory operating processes and performance and the interfaces with related functions is an essential responsibility of the position. The associate director is responsible to drive the continuous improvement of standard processes across medical & regulatory operations.  The associate director will develop and enable tools for process improvement to include operating techniques, employee development programs, and other improvement techniques to deliver high quality, measurable increases in efficiency, improvements in operations and bottom line results. 

 

Essential Areas of ResponsibilityLeads continuous improvement of medical & regulatory systems and operating processes, including local and global integration activities, to optimally support the achievement of Company goals.Manages process documentationMaintains viable and compliant standard operating procedures Defines and measures training and standard operating procedure activities. Manages training to assure compliance with regulations, standards and SOPs that support medical & regulatory operations in consultation with Clinical Quality Assurance.Develops curricula consistent with clinical development initiatives Ensures the development and delivery of learning solutions to meet business requirementsIdentifies and involves Subject Matter Experts in the development and delivery of training programsSelects vendors, specifies performance criteria, negotiates contracts and manages vendor compliance with specificationsMentors and trains medical & regulatory managers in the implementation of quality improvement strategies and work improvement tactics. Provides performance management and career development for direct reports. Ensures that direct reports maintain compliance and ethics in all activities.Assists the department head with conceptualization of improvement projects and with budget preparation justified according to impact on operations. Manages operating expenses to ensure work is within planned budget; identifies cost deviations and opportunities to apply resources and recommends actions.Participates in Company activities that leverage training resources for Company benefit.

Minimum Qualifications Baccalaureate degree in biological sciences, pharmacy, chemistry, or related field; advanced degree preferredA high level of written and verbal communication skillsExperience in the pharmaceutical or the medical device industry Understanding of the drug development processProven project and staff management skillsExperience with systems design and implementationExperience with the application of IT to process documentation, staff qualification, and training delivery and documentationProven success in developing and deploying training strategies and tacticsProven vendor selection and vendor management skills

 

For immediate consideration, please apply to: 

http://jobs-cephalon.icims.com/cephalon_jobs/jobs/candidate/login.jsp?jobid=1533