02 ago
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Astrazeneca
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Xico
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), non‐promotional 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 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 general 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 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, 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.
📌 Nominated Signatory Manager (Medical Compliance) (Xico)
🏢 Astrazeneca
📍 Xico