Location
Bangalore | India
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission.
Key Responsibilities
- Collaborate with stakeholders to develop and update processes and standards that will drive greater effectiveness and efficiencies globally
- Ensure stakeholders are informed and understand upcoming system and process changes that impact their business including value added.
- Collaborate with training manager to ensure training needs of end users are met.
- Oversee and Participate in testing, validation of systems and processes as needed
- Monitor applicable regulatory requirements assure compliance with Baxter and external standards
- May enter data into system or run data reports as needed
- SME in areas such as IDMP, XEVMPD, and Regulatory information quality management
- Maintains an expert, current knowledge of regulations, legislation, best practices and guidelines relating to RIM (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards, etc.).
- Ensures that all documents are filed and archived properly in accordance with Baxter requirements.
- Ensures Veeva Vault front end and backend support is run seamlessly.
- Guide users on how to request or modify CCDS RIM
- Annual review and confirmation of RIM access for users
- Monitor receipt of labels and track status on master list
- Format labels with header/footer/issuance date and execute upload into documentum and track status on master list
- Hands on experience on Nees, eCTD, or paper regulatory submissions using publishing systems is a plus.
- Experience in Verifying documentation to meet submission-ready standards is a plus.
Key skills and competencies
- Must have the ability to understand and reduce to practice Global Regulatory regulations and guidelines, i.e. FDA and EU regulations, and ICH guidelines.
- Scientific knowledge a plus, must have ability to discuss technical matters with cross-functional team members
- Ability to understand changing eCTD regulations and impact to the Baxter processes and systems a plus.
- Ability to operate in a matrixed environment and manage multiple activities, priorities and deadlines
- Exercise independent judgement
- Ability to lead and work with others to drive results
- Experience of working with external pharmaceutical data standards (pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.).
- Experience of working in Microsoft Excel and SharePoint (BI tools is a plus)
- Experience on Veeva Vault governance activities, loader sheets etc
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information.
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