Nominated Signatory Manager (Medical Compliance)

AstraZeneca; Ciudad de México; Presencial; MXN 734,000 - 1,102,000; Jornada completa

Descripción de la vacante

A leading pharmaceutical company in Mexico City is seeking a professional to manage the review and approval of promotional materials and donations. The ideal candidate has 3–4 years of experience in the pharmaceutical industry, strong regulatory knowledge, and excellent organizational skills. Responsibilities include training internal teams and ensuring compliance with policies. This position offers the opportunity to work within a diverse and inclusive team.

Formación

• 3–4 years in the pharmaceutical industry within medical, regulatory, or compliance functions.
• Hands-on management of approvals and documentation.
• Knowledge of promotional processes and scientific communication.

Responsabilidades

• Lead the review and final approval of promotional and non-promotional materials.
• Manage end-to-end donations management.
• Train and advise internal teams on guidelines and processes.

Conocimientos

Strong organization and planning

Attention to detail

Critical thinking

Document management

Verbal and written communication

Cross-functional collaboration

Integrity and confidentiality

Results orientation

Adaptability

Agile problem solving

Educación

Bachelor's degree in Health Sciences

Degrees in Business Administration or Law with relevant experience

Herramientas

NomSig

Veeva

Descripción del empleo

Typical Responsibilities

• Nominated approval: Lead the review and final approval of promotional and non‑promotional 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 second‑line managers, Business Unit Directors, General Manager).
• Approval workflow management: Maintain an efficient, traceable, and well‑documented review/signature process within current platforms (e.g., NomSig, Veeva).
• Donations: Coordinate and oversee end‑to‑end 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 second‑line 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.

Role‑Specific 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 non‑profit 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: Bachelor’s degree in Health Sciences (Medicine, Pharmacy, Biology) or related fields; degrees in Business Administration, Law, or Biochemistry with relevant experience are also accepted.
• Experience: 3–4 years in the pharmaceutical industry within medical, regulatory, or compliance functions; hands‑on management of 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, cross‑functional 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

26-nov-2025

Closing Date

04-dic-2025

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.