Job Summary - a concise overview of the job
The Sr Manager of training will be responsible and accountable for development of training materials and training sessions across all functions of R&D. The manager of training will be responsible for evaluating what training needs are required, development of those, and then execution. The Sr Manager of training will be responsible for ensuring the training curriculums are kept up to date and revised accordingly with shifts in regulations, industry standards, and changes within Endo. This individual is responsible to ensure s/he is an expert in industry standards as well as regulations inclusive of changes that may occur in order to have Endo as a leading biopharmaceutical company. This individual will also manage the R&D Operations Coordinator and other positions as defined.
The Sr Manager of training is also accountable for oversight of the Clinicaltrials.gov/Endo.com, Sunshine Act, and Clinicaltrials.com inquires process conducted by the R&D Operations Coordinator. The Sr Manager will also be responsible and accountable for business ownership of Endo’s CTMS system and ensure compliance and will also lead the initiative for evaluation of any new systems and implementation.
This individual will Co-Chair the R&D Clinical SOP committee to ensure the SOPs are aligned with industry standards and regulations inclusive of changes that may occur. This individual is accountable to ensure Endo R&D falls within current regulations at all times.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
§ Evaluate training needs and gaps
§ Develop SOPs and training curriculums
§ Conduct training sessions
§ Assist teams when re-training is needed and execute
§ Co-Chair the SOP committee
§ Responsible for the Functional Area Administrator duties for EndoAcademy for R&D Clinical, Medical Affairs, and Regulatory
§ Keep Endo Academy curriculums up to date and accurate
§ Evaluate and assist in Endo Academy enhancements as needed
§ Develop on boarding processes to ensure the on boarding experience is seamless for new hires and ensure all training needs for new hires are met in a timely manner
§ Ensure all training is clearly documented and documentation up to date
§ Be a Change Champion for Endo initiatives and systems as well as lead the path for new systems as needed and implementation
§ Create and maintain system manuals
§ System owner for CTMS and monitoring CTMS compliance and other systems as defined
§ Develop and schedule Lunch and Learn webinars within Endo R&D
§ Manage the R&D Operations Coordinator and other positions as defined
§ Accountable to oversee the Clinicaltrials.gov/Endo.com, Sunshine Act, and Clinicaltrials.com inquires process conducted by the R&D Operations Coordinator
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Design training curriculums per role/department
§ Conduct training sessions and re-training
§ Ensure documentation of all training is clear and up to date
§ Maintain training curriculums
CTMS System/Other systems Owner
§ Ensure CTMS is working within business needs
§ Monitoring CTMS compliance/enhancements
§ Evaluate future system’s needs, implementation, and business owner
Clinicaltrials.gov/Sunshine Act Process
§ Oversee the process the CT.Gov and Sunshine Act process
§ Manage the R&D Operations Coordinator and other defined positions
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ College degree.
§ Minimum of 10 -15 years of experience in pharmaceutical industry or clinical research site based experience
§ Previous experience with training development/execution
§ Previous system management experience
§ Previous people management experience
Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Expert in GCP and applicable FDA/EMEA/ROW regulations
§ Expert in training techniques
§ Expert in industry standards and changes in the industry
§ Knowledgeable in the interaction between functional areas
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Proficient in written and oral communication and experience in presenting to groups.
§ Expert with clinical trial and clinical data management systems, MS Office, electronic document management and other web-based systems.
§ Works autonomously under consultative direction toward long range goals.
§ Communicate proactively and appropriately and various levels within the organization and externally.
§ Anticipate problems and innovate effective plans for complex situations.
§ Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers.
§ Ability to prioritize and manage multiple tasks; strength in organization and planning.
§ System experience (e.g., CTMS, eTMF)
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Standard office environment and daily commute to assigned office location or regionally based.
§ Business travel ~25%.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.