Medical Affairs Compliance Lead, Saudi Arabia Johnson and Johnson

You will be responsible for:

1. Maintaining procedural documents management related to medical affairs within the organization. The primary objective will be to ensure that all procedural documents are properly created, updated, organized, and easily accessible to all relevant stakeholders. This will involve working closely with various teams including CQ PV RA, HCC and others to understand their documentation needs and ensuring compliance with established document management standards, document management systems Tru Vault and JC-qulize systems.

2. Supporting Saudi Arabia team in audit and inspection readiness efforts ensuring that the organization is well-prepared for internal and external audits and inspections and represent the medical affairs during audits and inspections.

3.span> Ensures complaint End to End process creation, distribution and tracking of EU ARMAs/CARMAs/Local ARMAs and creation of local DHPCs according to Local HA requirements across Saudi Arabi in partnership with Local PV team,

4. Maintains oversight of all team trainings to ensure excellence and compliance throughout every step of the process including medical role relates trainings, product trainings and other company related mandatory ones.

5. Collaborating with various stakeholders for Local compliance committee

Work closely with CQ team for medical affairs related (Change control, CAPA QI and Commitment records).

6. Leading Saudi Arabia medical affairs operational excellence

Work closely with medical leads and medical affairs team by monitoring the CIE/starshot metrics, following up on the team projects and tactical plan execution, oversee the team budget spend, and keeping track of the performance dashboards and EMEA content localization.

More detailed responsibilities:

1- Procedural documents Management:

• Collaborate with the medical lead for the local review, creation, revision, and maintenance for all procedural documents, encompassing POL, GDL, SOP, WI, BRQ, and other relevant materials. The documentation of this process within the JC Qulize system.

• Work closely with cross-functional teams, including subject matter experts, RA, CQ, PV, and HCC for creation, revision, and maintenance of local procedural documents.

• Ensuring that local regulations are incorporated in local impact assessments of Medical Affairs procedural documents and compliance is adhered to within the local controlled documents by timely sending Applicable procedural documents and document impact assessment and Local implementation documents in JC-Qulize.

• Responsible for distribution of all communications related to Medical Affairs Quality System to relevant Local Medical Affairs Roles

• Document tracking to ensure the compliant review and approvals via document management systems (Tru Vault)

• Efficient use of JC-Qulize to streamline and monitor the creation, tracking, and oversight of Medical Affairs regional procedural documents, encompassing critical aspects such as review, applicability assessment, and training assignment.

• Ensure that procedural documents adhere to relevant regulatory requirements, industry standards, and internal quality assurance guidelines. Collaborate with compliance and legal teams to address any potential gaps or risks.

• Training and Awareness: Coordinate training initiatives to educate medical affair teams on the updates and changes of procedural documents and ensure their adherence to established document control processes.

• Proactively identify opportunities to improve procedural document management processes, streamline workflows, and enhance overall efficiency. Make recommendations for updates or enhancements to document templates or formatting.

2- Audit and inspection readiness:

• Supporting OpCo team in audit and inspection readiness efforts ensuring that the organization is well-prepared for internal and external audits and inspections.

• This will involve working closely with various teams across the organization to identify and address gaps in compliance, documentation, and processes.

• Collaborate with cross-functional teams to identify audit and inspection requirements, gather necessary documentation, and ensure compliance with applicable regulations and standards.

• Assist in the development, maintenance, and organization of necessary documentation, such as policies, procedures, and work instructions, to support audit and inspection readiness.

• Preparation: Support the preparation and coordination of mock audits and inspections, ensuring that relevant stakeholders are informed and ready for the exercise.

• Gap Analysis: Perform regular gap analyses to identify areas of potential risks, and areas for improvement. Provide recommendations and assist in implementing corrective actions CAPA.

• Training and Awareness: Assist in the design and delivery of training sessions for Medical Team to raise awareness and understanding of audit and inspection requirements within the Opcos

• Continuous Improvement: Drive continuous improvement initiatives by actively participating in the identification and implementation of best practices and process enhancements related to audit and inspection readiness.