Job Description
Apoyo administrativo al área de Asuntos Regulatorios y Farmacovigilancia de Organon Colombia, siendo el líder y responsable de la gestión documental así como quien asegura la revisión periódica en las diferentes plataformas tanto externas (INVIMA), como internas, sistema CRM (Athena /Coupa) para mantener las actividades al dia y conforme a los procedimientos y tiempos establecidos para cada proceso (sometimientos, revisiones, plan de pagos, etc.).
La práctica se realizará en Bogotá en formato híbrido (2/3 días en la oficina).
Responsabilidades Primarias:
- Solicitud de buenas prácticas de manufactura (BPM): gestionar con los fabricantes la solicitud de BPMs actualizadas, con el fin de dar cumplimiento regulatorio en la vigencia del documento.
- Solicitud de certificados de un producto farmacéutico (CPP): gestionar con los fabricantes la solicitud de CPPs actualizadas, con el fin de dar cumplimiento regulatorio en la vigencia del documento.
- Solicitud de traducciones: gestionar la traducción de la documentación legal/técnica que es requerida por la autoridad sanitaria conforme a la normatividad vigente.
- Cargue de paquete técnico presentado a INIVMA: mantenimiento y cargue en la plataforma definida de la documentación sometida a la autoridad sanitaria, esto con el fin de garantizar la trazabilidad de las modificaciones presentadas para cada producto.
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Insertos e Informacion para el prescriptor: mantenimiento y cargue en la plataforma definida de la informacion farmacológica aprobada por la autoridad sanitaria para insertos e informacion para el prescriptor.
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Revisión de resoluciones emitida por la autoridad sanitaria: revisión de la resolución emitida por la autoridad sanitaria junto con el paquete técnico sometido, garantizando que lo aprobado por la autoridad corresponda a los soportes presentados.
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Solicitud de pagos: realizar la solicitud de pagos correspondientes a: tarifas INVIMA y proveedores
Educación minima requerida
Regencia en Farmacia, tecnología en química farmacéutica, tecnología en servicios farmacéuticos o tecnologías administrativas con interés en gestión administrativa.
Experencia y habilidades requeridas
- Deseable Conocimiento de buenas prácticas de manufactura
- Conocimiento en procesos de aseguramiento de la calidad
- Conocimientos en gestión documental
- Interés por áreas de apoyo administrativo
- Trabajo en equipo
- Flexibilidad y adaptación al cambio
- Comunicación efectiva
- Pensamiento analítico
- Compromiso
Secondary Job Description
Who We Are:
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
As an equal opportunity employer, we welcome applications from candidates with a diverse background. We are committed to creating an inclusive environment for all our applicants.
Search Firm Representatives Please Read Carefully
Organon LLC, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Annualized Salary Range
Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
Intern/Co-op (Fixed Term)
Relocation:
No relocation
VISA Sponsorship:
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Organon Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Organon and has not been reviewed or approved by Organon.
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Strong & Reliable Incentives — Quarterly bonuses and performance-based long-term incentives are frequently emphasized as meaningful components of total rewards, sometimes contrasted favorably with larger pharmaceutical firms. Recognition programs and an annual incentive process reinforce a pay-for-performance approach.
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Parental & Family Support — Twelve weeks of gender-neutral paid parental leave and twenty days of bereavement leave, including coverage for pregnancy loss, signal a robust family support offering. Caregiving concierge services and flexible leave practices further strengthen support for caregiving needs.
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Retirement Support — Retirement plans include employer contributions across many markets, with U.S. materials highlighting matching and additional company retirement contributions. This structure is presented as a core part of the financial benefits package.
Organon Insights
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What We Do
Organon is a global healthcare company with a portfolio of therapies and products in women’s health, biosimilars, and established medicines across a wide array of conditions and diseases. Our mission is to deliver impactful medicines and solutions for a healthier every day. This site is intended for residents of the United States and its territories. You are reminded to protect yourself against recruiting fraud from individuals, organizations or other entities claiming to represent Organon. All official Organon recruitment emails will come from accounts formatted as [email protected] or [email protected], and Organon will never conduct interviews by chat or email, or make job offers through social media or online forums. All candidates for roles at Organon will first meet with a recruiter and interview team, via Teams or in person. Organon will never ask you to make financial transactions on its behalf or ask you to receive or ship packages or goods. For more information on adverse event reporting, visit http://bit.ly/AEReporting. To read our community guidelines, visit http://bit.ly/OrganonCommunityGuidelines. Follow us on Twitter at Organon (@OrganonLLC). Follow us on Instagram at Organon (@OrganonLLC).
