Empleos actuales relacionados con Regulatory Project and Data Manager - Xoco - GSK


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 4 2024 The Systems Support Manager plays a crucial role in ensuring that existing and emerging Regulatory Systems are supported throughout their lifecycle - (i.e.: from the system’s initial implementation to the wider Organisation through subsequent releases and eventual...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Aug 27 2024 We are looking for an experienced and passionate Customer Experience Delivery Jr Manager to lead the design, implementation, and ongoing analysis & optimisation of agreed brands across selected Emerging Market Countries. Moreover, the role will play a critical role, supporting the...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Jacarepagua, Bogota Head Office, Mexico City Torre Mitikah **Posted Date**: Sep 5 2024 We are looking for a passionate person to act as our Digital Marketing Scrum Master for the LATAM markets. As a Digital Marketing Scrum Master YOU will be responsible to thinking and implementing innovation in the field of Customer Experience and Digital...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 23 2024 TBD **Why GSK?** **Uniting science, technology and talent to get ahead of disease together.** GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Aug 28 2024 The purpose of this role is to Provide support to all franchises with their processes / interactions with Healthcare Professionals (HCP) and Healthcare Organizations (HCO), such as: planning, implementation and closing of meetings and special interactions (conferences, webcasts, product...

  • Wref Group Site Manager

    hace 4 semanas


    Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Aug 29 2024 Responsible for relationship management with key stakeholders in GSK to ensure infrastructure and services support and facilitate the full range of business operations to meet the enterprise needs aligned and balanced against local business needs. Ensure local delivery of all facilities...


  • Xoco, México By Apple A tiempo completo

    Somos una marca emblemática 100% mexicana, con más de 40 años de tradición, que ofrece productos elaborados con ingredientes totalmente naturales, actualmente estamos presentes en toda la República Mexicana, Estados Unidos así como en 10 países de Latinoamérica. ¡En By Apple Cosmetics buscamos que seas tú mismo! By Apple Cosmetics somos tu aliado...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 19 2024 The MSL is a medical professional with strong scientific and therapeutic area expertise with an essential field-role focused on developing and maintaining peer-to-peer relationships with medical experts, key opinion leaders and key stakeholders. MSLs engage in in-depth medical and...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 19 2024 The MSL is a medical professional with strong scientific and therapeutic area expertise with an essential field-role focused on developing and maintaining peer-to-peer relationships with medical experts, key opinion leaders and key stakeholders. MSLs engage in in-depth medical and...

  • Journey Orchestrator

    hace 4 semanas


    Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 3 2024 **Position Name: Journey Orchestrator** This role will be responsible for designing & planning the campaign user journeys. Journey Orchestrator will act as the primary point of contact for the brand teams in ensuring that the campaign user journeys are well-orchestrated across all...


  • Xoco, México Hubtek LLC Mexico A tiempo completo

    **Hubtek** is a company that believes in young talent and seeks to support the development of its employees on a personal and professional level through learning experiences and growth opportunities. We support companies through our **Talent, Technology, and Training** services. We have been impacting the world **since 2018** and we want to keep pushing...


  • Xoco, México GSK A tiempo completo

    **Site Name**: Mexico City Torre Mitikah **Posted Date**: Sep 18 2024 Are you looking for an opportunity to manage the integration of pharmaceutical brands and execute the marketing campaign to optimize the customer experience? If so, this is the role for you. As the oncology marketing coordinator, you will be responsible for coordinating the...

Regulatory Project and Data Manager

hace 3 meses


Xoco, México GSK A tiempo completo

Site Name:
Mexico City Torre Mitikah

Posted Date:
Nov

**_

Your Responsibilities_**:
This role gives YOU the opportunity to lead key activities to progress YOUR career, the main of these are:

  • Independently use judgement, strict adherence to GSK and IRM plan quality and process expectations, industry and regulatory standards and drug development experience to deliver high quality integrated Regulatory Development Plans (RDPs) based on input from GRLs and project teams on the overall development strategies associated with projects (asset by indication).
  • Responsible for maintaining integrated Regulatory Development Plan (RDP) for operationalizing the Global Regulatory Strategy (as defined by the GRL), ensuring regulatory deliverables, timelines, and resource needs are accurately captured for each phase of development.
  • Manage work packages (add/delete/move as appropriate) within the RDP to ensure the necessary Regulatory deliverables and agreed Global Reg Strategy are reflected; Must understand the importance of RDPs reflecting accurate development strategies through the management of these work packages and associated logic and touchpoints with other plan types.
  • Review and manipulate, as needed, the predecessor/successor logic within the RDP, create scenarios, and communicate what is driving Regulatory deliverable dates to the team and other PMs working on the project.
  • Support R&D Governance reviews, e.g. Development Review Board (DRB) and Portfolio Investment Board (PIB), at key stage gates in the development process (e.g. C2P2, C2P3, C2F&L) as well as Dynamic Portfolio Review (dPR) facilitate RMT and broader Regulatory review of resource forecasts (both external and internal project expenses
  • EPE, IPE, and FTE); Ensure any requested data is complete, accurate, and fit for purpose for informing business decisions.
  • With support from line managers/RPMs, as needed, build the associated schedules to drive Regulatory resource forecast estimates; forecast cost (EPE) and resource (FTE/IPE) associated with integrated plans.
  • Partner with key stakeholders including RMT members and functional Project Managers, etc. to ensure plan schedule alignment to intended strategy.

_ Why you? _

_Basic Qualifications:
_
We are looking for professionals with these characteristics to achieve our goals:

  • Bachelor's Degree in a biological, healthcare or scientific discipline or extensive experience within the drug development environment and training in project management principles/tools.
  • 5 years of experience understanding of pharmaceutical industry, drug development environment, and R&D processes and objectives.
  • Project management experience, preferably in the pharmaceutical industry or in a regulatory environment.
  • Experience with project management principles and systems (e.g. Planisware), resource management and reporting features (e.g. Spotfire).
  • Advanced English Level.
  • Microsoft Office knowledge.

_ Preferred Qualifications:
_
However, if you have the following, it would be a plus:

  • PMI or equivalent certification.
  • Knowledge of Regulatory Affairs responsibilities from preIND through postapproval

_ Why GSK? _


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.

A place where they can be themselves - feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Why Us?


GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organization where people can thrive.

Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.

Our success absolutely depends on our people.

While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.

We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and In