Medical Affairs Compliance Lead, Saudi Arabia

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Our expertise in Innovative Medicine is informed and inspired by patients whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments finding cures and pioneering the path from lab to life while championing patients every step of the way.

Learn more at are searching for the best talent for the Medical Affairs Compliance Lead Saudi Arabia role to be based Cairo Egypt.

Purpose: The MACL role emphasizes the importance of Medical operational excellence and compliance across various aspects of our operations. The primary objective of this role is to ensure that our processes and procedures are implemented to achieve the highest level of operational efficiency and adherence to all local regulations and ensure strict adherence to internal policies and external requirements and are in line with applicable laws and regulations.

Furthermore the role requires collaborating with various stakeholders across the organization CQ PV RA HCC and others to promote a culture of excellence and compliance. Effective communication and interpersonal skills are essential in order to engage and educate team members on the importance of Medical affairs operational excellence and compliance fostering a shared commitment to these goals.

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. 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.

3- Pharmacovigilance activities: End to End Risk Management measures implementation and ARMA Power app update:

• End to End Risk Management measures process implementation

• Oversight of Implementation/Retirement of EU ARMAs/CARMAs/Local ARMAs and Implementation of DHPCs within Saudi Arabia

• Ensure complaint localization of EU ARMAs/CARMAs/Local ARMAs and creation of local DHPCs according to Local HA requirements within Saudi Arabia.

• Ensure compliance of distribution plans according to company SOPs and relevant HA regulations.

• Share metrics with respective functions within the LOC for awareness and/or action.

• ARMA Power App continuous update to reflect current situations.

4- Maintain 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 trainings:

• MACL will be responsible for coordinating and managing the entire training lifecycle from initial assignment to follow up on completion.

• Coordinate and assign training to team members based on their Tas roles and job responsibilities.

• Ensure that training materials are up-to-date and in compliance with company policies and regulations.

• Monitor and track the progress of all team members training activities. - Proactively identify and address any issues or challenges that may arise during the training process.

• Conduct regular audit checks to ensure compliance and adherence to training protocols.

• Maintain accurate records of training completion and generate reports as required for Audits and inspections

• Continuously evaluate the effectiveness of training programs and recommend improvements.

5- Systems user:

• Grant medical team access for company governance systems

• iMedical Review

• iMedical knowledge

• local Truvault Superuser

• Assignment for new users for Truvault production

• Support medical affairs team for Procedural documents submission update and approval.

• Maintain oversight of EMEA regional medical affairs documents to ensure a compliant life cycle from effective dates periodic review version updates and obsoletion including SOPs WI and LIDs.

• EMERGE Business admin.

• EMERGE project launch excellence for all GxP functions.

• Communicate EMERGE steps and timelines with employees and people leaders across EMEA.

• Ensure GxP team members compliance with uploading JD and SOE in timely manner and people leaders for adherence for EMERGE procedure by having all JD SOE and ITP for all GxP team members

• JC-Qulize roles

• Local Role to handle Saudi Arabia MA local impact assessments.

• Evidence Generation Systems Superuser (ReCAP JPUBs)

• Responsible for ensuring the compliant assignment of different roles across evidence generation systems.

6- Medical Affairs Operational Excellence:

• Collaborate with the medical leads and medical affairs team to enhance the medical affairs team operations through the following

• Following up on the CIE/Starshot metrics for the team and sharing a bi-monthly report with medical leads.

• Collaborating with the medical education team and following up on the tactical plans execution and events finalization.

• Monitoring the team budget spend by TA and liaising with the finance team.

• Monitoring the medical insights submission for the medical team.

• Overseeing the TOV disclosure process and liaising with disclosure team to meet the set deadlines.

• Monitoring the EMEA generated contents localization.

Qualifications/Requirements:

• Degree in a relevant scientific (life sciences) discipline.

• Fluency in English and Arabic languages required.

• Excellent verbal and written communication skills including ability to effectively communicate with internal and external customers.

• Excellent computer proficiency e.g. MS Office

• Strong analytical Excel skills (Pivot Tables If statements VLOOKUPs).

• Knowledge in business intelligence tool (Tableau) is preferred.

• Proficiency in using TrackWise COMET PQMS TruVault CURVE PRISM/Voyager JC-Qualize IMPACTO J&J Systems.

• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution.

• Must be able to work independently with minimum supervision to meet tight deadlines and maintain a positive attitude.

• Excellent interpersonal collaboration networking and communication skills self-motivated clear thinker.

• Proven ability to prioritize risks to manage multiple critical issues. Strong analytical thinking communication decision-making and leadership skills for interaction with external and internal customers and partners.

• Flexibility adaptability and strong organization skills.

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