Health Care Compliance Specialist-00000PUJ
Description
Description
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.
Searching the best talent for: Health Care Compliance Specialist
General description:
The Health Care Compliance Specialist is responsible for Healthcare Compliance programs transactions for the Health Care Compliance organization in Mexico. He or she supports planning, trainings, assessments, testing and other varied HCC functions. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans
Main responsibilities:
- Organizing and implementing training (face to face, e-university) to internal and external audience
- Maintain employee and/or 3rd. party certification and training attendance records
- Assisting in HCC reviews and approvals requests
- Carrying out day-to-day tasks such as data collection, analysis and reporting,
- Supporting new procedure harmonization and implementation
- Assisting in software support for HCC systems
- Assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis,
- May serve as the first line of communication to the business for reviewing local requests and documentation.
- Assist in implementation of modifying regional global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
- Support Implementation of Cluster strategy & plan aligning with the businesses and J&J Office of Compliance
- Support the HCC operations group in implementation of education, training, and regular communications on HCC to all covered employees, including local sales, marketing, finance, HR, managers, supply chain and directors at the local level
- Support HCC Managers in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
- Support the implementation of local testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
- Assisting in coordinating preparations for Corporate Internal Audits
- Assist in the implementing and following up on the Management Action Plan as assigned by the HCC Manager or Director
- Report unplanned deviations and supporting the HCC Officer Cluster Lead in Managing day-to-day inquiries, allegations and investigations
- Implement the escalation process for serious allegations, as appropriate
- Collect and Provide metrics to the HCC Officer and Operations group as assigned
- Partnering with the Global/Regional Operations team to:
- Implement business specific policies and SOP’s and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Implement IM systems that collect, audit, analyze, and report compliance information
- Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
- Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
- Execute Testing & Monitoring plans and programs
- Ensure external reporting requirements are met per local regulations
Reports to: HCC Manager
Qualifications
Experience:
- Position reports into the Enterprise Wide compliance organization
- Requires strong communication, organisational and analytical skills
- Must be able to work independently
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilence, Regulatory, Information Management or Auditing.
- Proven track record in delivering results, self starter, hands on and ability to manage complexity a must
- Industry related experience preferred: HCC, Regulatory Affairs, and Compliance Experience in the Medical Device or Pharmaceutical industries.
- Ability to manage conflicts in an open and constructive manner
Leadership imperatives:
Connect
Shape
Deliver
Lead
Other Competencies and skills
- Requires strong communication, organisational, analytical skills, leadership, and customer service oriented.
- Must be hands on and have sense of urgency.
- Must be able to prioritize activities and negotiate due dates.
- Ability to manage conflicts in an open and constructive manner.
- Proven track record in delivering results, self starter.
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory, Information Management or Auditing.
- Industry related experience preferred in the Medical Device or Pharmaceutical industries.
- coach skills; verbal and written communication abilities; listening skills; problem analysis; problem solving; customer service orientation; organizational skills; big picture orientation with attention to details; initiative; judgment; adaptability; team work; stress tolerance; resilience; negotiation skills.
Submit your resume by: May 20th
Primary Location: México D.F.
Organization: Johnson & Johnson Medical Devices
Primary Location:Latin America-Mexico-Distrito Federal-Mexico City
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Health Care Compliance and Privacy
Description
Description
Our companies of MD & D (Medical Devices & Diagnostics) provides treatment technologies in the areas of orthopedics, spine, sports medicine and neurology, sutures and tissue repair, biopharmaceutical, minimally invasive surgery, cardiovascular disease and diabetes care.
Searching the best talent for: Health Care Compliance Specialist
General description:
The Health Care Compliance Specialist is responsible for Healthcare Compliance programs transactions for the Health Care Compliance organization in Mexico. He or she supports planning, trainings, assessments, testing and other varied HCC functions. This person is also responsible for maintaining existing programs and implementing activities related to Management Action Plans
Main responsibilities:
- Organizing and implementing training (face to face, e-university) to internal and external audience
- Maintain employee and/or 3rd. party certification and training attendance records
- Assisting in HCC reviews and approvals requests
- Carrying out day-to-day tasks such as data collection, analysis and reporting,
- Supporting new procedure harmonization and implementation
- Assisting in software support for HCC systems
- Assist in the harmonization, preparation, updating and implementation of all HCC written policies and procedures on an ongoing basis,
- May serve as the first line of communication to the business for reviewing local requests and documentation.
- Assist in implementation of modifying regional global strategies into regional and local level and where needed sector level, based on appropriate local needs, goals and objectives, taking into account local external regulatory trends and environment
- Support Implementation of Cluster strategy & plan aligning with the businesses and J&J Office of Compliance
- Support the HCC operations group in implementation of education, training, and regular communications on HCC to all covered employees, including local sales, marketing, finance, HR, managers, supply chain and directors at the local level
- Support HCC Managers in the self-assessment and risk assessment processes to detect process gaps & inconsistencies
- Support the implementation of local testing & monitoring plan to demonstrate that the HCC program is effective and participate in execution where appropriate
- Assisting in coordinating preparations for Corporate Internal Audits
- Assist in the implementing and following up on the Management Action Plan as assigned by the HCC Manager or Director
- Report unplanned deviations and supporting the HCC Officer Cluster Lead in Managing day-to-day inquiries, allegations and investigations
- Implement the escalation process for serious allegations, as appropriate
- Collect and Provide metrics to the HCC Officer and Operations group as assigned
- Partnering with the Global/Regional Operations team to:
- Implement business specific policies and SOP’s and customize global/regional policies & procedures and education & training materials to reflect local requirements
- Implement IM systems that collect, audit, analyze, and report compliance information
- Deploy policies and procedures that align and monitor company activities to ensure compliance with government, private, legal and company HCC standards
- Implement HCC training programs, including new employee orientation, periodic training on specialized subjects, and annual refresher training
- Execute Testing & Monitoring plans and programs
- Ensure external reporting requirements are met per local regulations
Reports to: HCC Manager
Qualifications
Experience:
- Position reports into the Enterprise Wide compliance organization
- Requires strong communication, organisational and analytical skills
- Must be able to work independently
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilence, Regulatory, Information Management or Auditing.
- Proven track record in delivering results, self starter, hands on and ability to manage complexity a must
- Industry related experience preferred: HCC, Regulatory Affairs, and Compliance Experience in the Medical Device or Pharmaceutical industries.
- Ability to manage conflicts in an open and constructive manner
Leadership imperatives:
Connect
Shape
Deliver
Lead
Other Competencies and skills
- Requires strong communication, organisational, analytical skills, leadership, and customer service oriented.
- Must be hands on and have sense of urgency.
- Must be able to prioritize activities and negotiate due dates.
- Ability to manage conflicts in an open and constructive manner.
- Proven track record in delivering results, self starter.
- Background may include Compliance, Finance, Sales and Marketing, Medical Affairs, Legal, Pharmacovigilance, Regulatory, Information Management or Auditing.
- Industry related experience preferred in the Medical Device or Pharmaceutical industries.
- coach skills; verbal and written communication abilities; listening skills; problem analysis; problem solving; customer service orientation; organizational skills; big picture orientation with attention to details; initiative; judgment; adaptability; team work; stress tolerance; resilience; negotiation skills.
Submit your resume by: May 20th
Primary Location: México D.F.
Organization: Johnson & Johnson Medical Devices
Primary Location:Latin America-Mexico-Distrito Federal-Mexico City
Organization: Johnson & Johnson Medical Servicios Profesionales S. de R.L. de C.V. (7243)
Job Function: Health Care Compliance and Privacy