Senior Associate, Global Submission Management

Job DescriptionLead/support various Clinical Trial and Marketing Application type submissions and associated Global/Submission Content Plans.- Participation in information system and software update projects as well as ongoing system validations.- Serve as point of contact between Amgen's functional contributors and external partners, to ensure smooth...

Career Category Health Economics Global HEOR Value Writing Senior Associate Department Global Health Economics Outcomes Research HEOR Job Family Health Economics Job Type Full-Time Location Hyderabad India Reports To Global Value Writing Team Lead Position Summary The Global HEOR Value Writing Senior Associate plays a critical role in...

Job DescriptionThe Senior Associate, Clinical Trial Submission Management, will help ensure the technical compliance of our Clinical Trial submissions via the smooth compliant flow of information between all functional areas, internal and external to GRAAS, local offices, external partners and regulatory authorities. This vital role is assigned to one or...

Job DescriptionRoles & Responsibilities:- Be assigned to one or more Amgen products under development to ensure Clinical Trial Application approvals in the EU throughout the whole study lifecycle. As technical experts in the EMA Clinical Trial Information System (CTIS), ensure compliance with the EU Clinical Trials Regulation (EU CTR) for every Clinical...

Job DescriptionThe Senior Associate, Data Management, will help drive key business operation initiatives within Veeva RIM Vault, ensuring alignment with global regulatory requirements such as IDMP, EU CTR, and other emerging regulations.You will lead efforts to implement and support regulatory processes, ensuring compliance, efficiency, and the delivery of...

Global University Systems is an international education group that empowers students to transform their lives through education. We believe education drives careers, lives, and society forward, enabling a brighter future for all. Our network of 30 institutions offers the broadest range of industry-relevant skills through inclusive, accessible, and...

Global University Systems is an international education group that empowers students to transform their lives through education. We believe education drives careers, lives, and society forward, enabling a brighter future for all. Our network of 30 institutions offers the broadest range of industry-relevant skills through inclusive, accessible, and...

Job DescriptionMajor accountabilities:- Is responsible for implementing regulatory strategy and managing operational activities for assigned medium regions.- Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic...

Job DescriptionAudit & Assurance: Senior Associate/Senior - US GAAP, UK GAAP, IFRS, FRS 102Our Audit & Assurance team is one of the growing teams in our office. As part of our team, you will provide our clients' your valuable inputs by using your skills and experience to give companies, investors, and regulators confidence in the validity of financial...

Job DescriptionR1 is a leading provider of technology-driven solutions that help hospitals and health systems to manage their financial systems and improve patients experience. We are the one company that combines the deep expertise of a global workforce of revenue cycle professionals with the industry's most advanced technology platform, encompassing...