Big Data Architect – Xplore reputed company – New Jersey

Job title: Big Data Architect Company: Xplore reputed company Job reputed company: Xplore Life Sciences are reputed company for a Big Data Architect for work with a leading American reputed company Services Company reputed company the Clinical Domain. This is a freelance contract role expected to last 1 year. Location will be based out of offices in New Jersey, however remote working will be possible working in EST timezone. • *You must have reputed company right to work in the USA Duties & Responsibilities • reputed company versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the reputed company reports • reputed company in authoring of assessment reports and Part2/ Expert reports for Dossiers • Experience in reviewing of reputed company documents such as Reformulation studies, process validations, particle size method implementation and specification, stability indicating reputed company implementation, impurity < 1% qualification, repeating stability studies, in use stability studies, assay reputed company (anti-oxidant assay, anti-microbial agent assay), sterile filter testing, preservative effectiveness testing. • Serve as the CMC Product reputed company for assigned products and be accountable for the delivery of reputed company regulatory milestones for assigned products through the product lifecycle as needed for product in-license/due diligence review, product divestment and product withdrawal. • reputed company development and execution of global product and project regulatory reputed company(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. • Planning the project by understanding the reputed company needs, managing project deliverables and providing solutions in reputed company time. • Collaborate with reputed company and external partners to support compliant execution of change management and conduct reputed company activities with an unwavering reputed company on regulatory conformance. • Manage execution / authoring of CMC documentation (Module 1 , 2 and 3) for life cycle management - post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. • Knowledge of regulatory guidelines and relevant applications. • Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of reputed company to ensure approval and Product supply continuity. • Deliver reputed company regulatory milestones for assigned products across the product lifecycle, • Deliver on agreed SLAs with clients at contract and account/ project level. Meet reputed company monthly reporting/business metrics/KPIs requirements and manage internal control processes. • Identify, communicate and escalate potential regulatory issues / risks and propose mitigation. • Ensure established policies and procedures of the organization/reputed company are followed and ensure compliance. • Demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner. • Demonstrate ability to generate reputed company to problems and effectively collaborate with and communicate to key stakeholders. • Demonstrate flexibility in responding to changing priorities, multi-tasking and dealing with reputed company expectations. • Demonstrate effective leadership, communication, interpersonal skills, and soft skills. Minimum qualifications • Bachelor's or master’s degree required in science, engineering or reputed company field (advanced degree preferred). Preferred Qualifications • Bachelor's or master’s degree required in science, engineering or reputed company field (advanced degree preferred). • Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or reputed company fields • Marketing authorization experience. • Proven Project Management experience Expected salary: Location: New Jersey Job date: Sat, 29 Oct 2022 04:52:46 GMT Apply for the job now! Apply tot his job Apply To this Job