Office Administrator supporting Global Financial Crime team with administrative tasks and project management. Ensuring proper communication, coordination, and support for multiple initiatives.
About the role
- eCTD publishing Manager supporting data mapping of eCTD metadata for Vertex Pharmaceuticals. Involves Excel work against data extracts from Veeva Vault RIM with a focus on eCTD 4.0 submissions.
Responsibilities
- Support data mapping of eCTD metadata from legacy publishing system into future state system
- Support activities in preparation of enabling eCTD 4.0 submissions
- Work mostly conducted in Excel, working against data extracts from Veeva Vault RIM
- Own portions of the data migration mapping to enable Veeva Publishing as well as preparation activities for eCTD 4.0 enablement, including, but not limited to:
- Mapping legacy eCTD metadata into Veeva RIM relationships
- Identifying out of date eCTD relationships
- Suggesting updates to align with historical dossiers and enable future lifecycle management
- Corrections to the Veeva RIM archive as needed
- Mapping of current submission types and subtypes against Veeva and HA recommended nomenclature
- Mapping of existing submission records and fields into updated data models and fields
- Mapping eCTD 4.0 functionality in Veeva Publishing and executing end user testing as needed
Requirements
- Bachelor's degree, with a preference for life sciences or technology area
- Typically requires at least five to seven years hands-on technical experience with eCTD publishing, either in Veeva Vault or similar publishing tools
- Experience with Veeva Vault RIM
- In depth hands on experience with eCTD publishing software, detailed understanding of eCTD metadata
- Proficient in Microsoft Office, especially Excel and formulas, e.g. Vlookup and pivot tables.
- Ability to organize and manage tasks with firm deadlines
- Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner.
Benefits
- Compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer.
- Overtime pay, in accordance with federal and state requirements
Job title
Job type
Experience level
Salary
Degree requirement
Tech skills
Location requirements
GRA CMC Lead driving regulatory strategies for pharmaceutical and vaccine products. Collaborating with cross - functional teams and directly influencing drug approvals through negotiations.
Manager of Regulatory Affairs driving regulatory strategies for product launches and compliance. Collaborating with cross - functional teams to enhance product development and advertising campaigns.
Compliance Senior Advisor assessing regulatory risks and providing compliance guidance for Atlantic Union Bank. Managing compliance risk assessments and collaborating with business units.
Senior Manager providing strategic regulatory advice for promotional issues at Bristol Myers Squibb. Ensuring compliance with policies, guidelines, and regulations relevant to pharmaceutical promotion.
Analyst supporting Global Customs & Trade Compliance at Bristol Myers Squibb. Focus on coordinating customs and trade management and data generation for import/export operations.
Analyst supporting Global Customs & Trade Compliance at Bristol Myers Squibb. Focused on customs coordination, data management, and regulatory compliance in a pharmaceutical context.
Digital Technology Senior Specialist focused on regulatory compliance in energy technology. Collaborating with product teams and ensuring audit preparedness and structured frameworks for SOC2, EU AI Act, and more.
Regulatory Affairs Officer leading compliance for PayJoy's credit products in Indonesia's fintech landscape. Interfacing with regulators and ensuring adherence to local financial regulations.
Contracts Manager responsible for managing regulatory contracts in compliance for credit provider in emerging markets. Collaborating with teams to ensure legal soundness and risk management in business transactions.