Información de la oferta


T3RS

Medical Operation Specialist

REGULATORY AFFAIRS SPECIALIST


A convenir

COLOMBIA BOGOTA BOGOTA D.C.
860001942
Bayer S.A.
TIEMPO COMPLETO
3 A 4 AÑOS
PROFESIONAL
1
11/03/2025
24/03/2025
Fabricación de productos farmacéuticos, sustancias químicas medicinales y productos botánicos de uso farmacéutico
University degree in Medicine, Pharmacy, Biology, Biochemistry. (Master and above desirable).
Responsible for operationalization of Scientific Medical Events, HCP Medical interactions, Advisory Board and Medical Sponsorship Events (pre, during and post) bringing excellence in execution and ensuring the properly conduction of event or interaction, the mandatory documents according to local laws and Bayer procedures/process, the payment process, liaise with the CEOP in aligning/harmonizing the process followed by commercial functions related to their Scientific Events, HCP interactions, PO / NGO interactions, Advisory Board and Sponsorship Events.
Support Medical Governance Lead in Quality Checks and Monitoring process, including a regular systematic process review of all Corrective Actions Preventive Actions (CAPAs) in PACA countries to ensure that all MA and Commercial relevant quality issues have been thoroughly investigated for root cause, implemented effective action plans and conducted verification with appropriate effectiveness checks and all tasks are completed on time.
Support Medical Governance Lead in the Audits & inspections readiness, conduct and follow-up.
Contribute to the compliance of medical governance in MA as well as Bayer Pharma in collaboration with LATAM/global medical governance, local LPC, Americas LPCx, GBS and others.
Responsible for all the Medical Systems (HIREP, My Learning/ACDL, Time Tracking, and others…).
Responsible for Onboarding Process and support the Medical Team on the Onboarding Process.
Responsible for Medical Training for Pharma, including the implementation of an appropriate training / information sharing for medical related local QSDs and topics, in cooperation with respective functions, to ensure proper awareness and implementation of global and/or local relevant regulations and QSDs.
Responsible of HCPs ToV report according to Global Crystal Project (Non-Crystal countries) and applicable Local Legislations in compete alignment with EDM responsible.
Review all relevant global Quality System Documents (QSDs) and local country regulations and ensure proper implementation of activities in the Bayer affiliate.
University degree in Medicine, Pharmacy, Biology, Biochemistry. (Master and above desirable).
Advanced English proficiency.
At least 3 years of experience in Medicine, marketing, Project processing or events organization.
Team player and cooperative.
Solves problems for the good of all and has a positive reputation.
Promotes and adheres to PH Code of Conduct, all laws and regulations and applicable policies and procedures.
Demonstrates ethical leadership and responsibility.
Regularly assesses plans and priorities and redirects efforts appropriately to achieve goals.
Values planning but also identifies urgent situations and readily jumps into action.
Builds and maintains expert therapeutic area knowledge and establishes self as an effective scientific resource.
Drives results, plans and aligns, collaborates.
Strategic mindset cultivates innovation.

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