Vacancy expired!
Client is a leading, “global ten” provider of custom information technology, consulting and business process outsourcing services, and serves primarily Global 2000 companies. The firm employs more than 150,000 people and works with 805 active clients across banking & financial services, insurance, healthcare, life sciences, retail/consumer, manufacturing, energy, communications, and media. Since being spun-out as a public entity in 1998, the company has grown at an unprecedented rate, with anticipated revenue of >$8, making the fastest growing IT services company over the last 10 years, and certainly the most profitable now featuring a market capitalization greater than $18B. Client is a member of the NASDAQ-100 Index and the S&P 500 Index and part of “Fortune 500” list.Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.Demonstrated knowledge and understanding of company Core Data Sheets (CDS) and the dynamics of Labeling Team purpose and objectives.Consolidate labeling versions and comments from Labeling reviewers and Regulatory Authorities.Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).Prepare comparison tables for labeling team discussions.Manage the document status and notify internal stakeholders of the availability of labeling documents.Finalize documents post QCOrder SPL for USPIs, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing). Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required Must be able to construct a Company Response (MAH response) for health authority questions Masters in Life Sciences Understanding of key regulatory and Labeling principles and SOPs
- Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Proficient in speaking publicly to senior management when required
- Must be able to construct a Company Response (MAH response) for health authority questions
- Masters in Life Sciences
- Understanding of key regulatory and Labeling principles and SOPs
- Should be open to work in any shift as per the business requirement Masters 's/ Bachelor's degree required in science, engineering or related field (advanced degree preferred)
Vacancy expired!