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 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 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.