Nominated Signatory Manager (Medical Compliance)

The Nominated Signatory Manager (Medical Compliance Manager) coordinates reviews and grants final approval for materials and activities related to promotion engagement with Healthcare Professionals and Organizations (HCPs/HCOs) nonpromotional events and scientific corporate and regulatory materials as well as the donations process; ensures compliance with internal policies local and international regulations and industry codes. Acts on behalf of the Company and in a personal professional capacity ensuring that external communications and activities are ethical transparent and fully traceable.

Typical Responsibilities

• Nominated approval: Lead the review and final approval of promotional and nonpromotional materials activities and HCP/HCO events in accordance with internal policies industry codes and applicable regulations.
• Governance and accreditation: Serve as an accredited Nominated Signatory for the designated countries/functions; represent the final position of the review team (Marketing Medical first and secondline managers Business Unit Directors General Manager).
• Approval workflow management: Maintain an efficient traceable and welldocumented review/signature process within current platforms (e.g. NomSig Veeva).
• Donations: Coordinate and oversee endtoend donations management (intake eligibility assessment approval documentation traceability and evidence of use) in partnership with Medical Legal Compliance and Finance.
• HCP/HCO: Review and approve documentation for HCP/HCO onboarding; ensure adherence to processes and requirements.
• FMV and events: Process global/local requests for review and approval of Fair Market Value (FMV) for speakers/guests in the current platform; manage potential conflicts of interest.
• Internal training: Train and advise internal teams on guidelines and processes within the scope of NomSig and Medical Operations.
• Policies and SOPs: Contribute to the update and maintenance of local policies and procedures aligned with global policies and local regulations.
• Compliance monitoring: Execute and report first and secondline monitoring; track Medical Operations KPIs related to NomSig and donations.
• Audits: Participate actively in internal and external audits; prepare required information and evidence.
• Congresses/delegates: Manage and update the annual congresses and delegates plan ensuring process compliance.
• Transparency and integrity: Ensure activities are conducted without improperly influencing medical or commercial decisions and in adherence to ethical principles.

RoleSpecific Responsibilities

• KPI compliance: Ensure achievement of Medical Operations KPIs for review/signature processes donations HCP/HCO and FMV.
• Regulatory alignment: Verify proper alignment of local procedures with global policies and applicable national regulations.
• Donations detailed management:
  • Receive review and manage requests from healthcare institutions medical organizations and nonprofit entities.
  • Verify eligibility and documentation in line with internal and regulatory requirements.
  • Record track and ensure traceability in corporate platforms.
  • Document purpose value beneficiary contracts acceptance letters and evidence of use.
  • Monitor timelines flag deviations and prepare reports for audits/authorities as applicable.
• FMV and COI: Review and approve FMV in the current platform; report and manage conflicts of interest (COI).
• Continuous improvement: Identify opportunities to improve the NomSig process drive standardization and enhance operational efficiency.

Essential

• Education: Bachelors degree in Health Sciences (Medicine Pharmacy Biology) or related fields; degrees in Business Administration Law or Biochemistry with relevant experience are also accepted.
• Experience: 34 years of managerial experience in the pharmaceutical industry across medical regulatory and compliance functions with hands-on responsibility for approvals and documentation.
• Knowledge: Promotional processes and scientific communication; interpretation of regulatory/legal/compliance guidelines; proficiency with approval platforms (e.g. NomSig Veeva).
• Skills: Strong organization and planning attention to detail critical thinking document management verbal and written communication crossfunctional collaboration integrity and confidentiality results orientation adaptability and agile problem solving.
• Audit experience
• Intermediate/advanced English as required.

Preferred

• Ability to understand and draft corporate policies procedures and guidelines on promotion and scientific exchange.
• Knowledge of applicable legislation and codes of practice for promotional activities.
• Training/certifications in compliance regulatory or quality systems.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.