Job title: Sr Optimization Specialist
Job description: JOB DESCRIPTION Summarized Purpose: Serves as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned initiat
JOB DESCRIPTION Summarized Purpose: Serves as subject matter expert to design, develop, deliver and improve products, programs, and services in order to optimize processes, behaviors, performance and audit readiness. Accountable for assigned initiatives aimed at supporting and/or ensuring quality operational delivery via efficient and effective processes, associated systems, training and communications. Interprets data on complex issues, leads teams and makes good business decisions with support. Essential Functions and Other Job Information: Supports implementation, configuration and maintenance of Veeva Vault RIM system. Supports the Regulatory Affairs systems on a global level. Proactively collaborates with initiative leads and management to prepare organize, coordinate, document and/or provide the development and delivery of department products and services to a globally dispersed, cross-functional audience in support of business outcomes and industry compliance requirements. Develops varied support materials, presentations, and/or tools to support department’s remit and strategies. Proactively collaborates with initiative leads and management to develop, optimize and improve processes, associated systems/applications, training and communications. Leads small to medium-scale process improvement initiatives. Develops process improvement processes and solutions. Identifies and collates information required to assess compliance with processes and to prioritize business process improvement needs. May review, assess and update procedural documents for overall compliance with current processes. Performs special projects, assignments and administrative tasks per business needs. Provides training and guidance to junior team members. Job Qualification Job Knowldge A seasoned, experienced professional with a full understanding of area of specialization resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position. Education and Experience: Bachelor’s degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Significant experience in regulatory affairs, regulatory publishing, pharmacovigilance or clinical research, is preferred. Knowledge, Skills and Abilities: Thorough understanding of procedural documents Strong understanding of process improvement fundamentals Solid investigative and analytical skills Strong negotiation skills Thorough understanding of regulatory affairs/publishing/pharmacovigilance/clinical managementtechnology and systems, and strong computer skills Effective judgment, decision making, escalation, and risk management skills Effective oral and written communication skills including the ability to communicate in English, both orally and in writing Strong interpersonal skills and problem solving ability Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting Strong attention to detail Thorough understanding of regulatory guidelines and directives (eCTD, IDMP, GCP) Strong creative and critical thinking skills Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Ability to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May require travel. (Recruiter will provide more details.)
Location: Bangalore, Karnataka
Job date: Thu, 27 Jan 2022 23:47:43 GMT
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