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Associate Regulatory and Start-Up Manager


Source:
TIMESJOBS.COM
Location:
Bengaluru, KA
Date:
12-11-2016
Job Code:
58258520
Categories:
  • Biotechnology & Science
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Job Details

Oversee the execution of Start Up (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed RSU strategy. Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.Develop, implement and maintain the RSU Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy.Ensure collaboration across RSU, including communication with regions and countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance, as required.Provide specialist regulatory and technical scientific support to facilitate efficient initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional projects during initial start-up and maintenance phase as an integral member of the study management team.Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; identify regulatory complexity and challenges and offer creative and practical solutions to support the bid process and subsequent execution of the RSU plan.Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.Ensure overall project efficiency and adherence to project timelines and financial goals; report performance metrics and out of scope activities as required.Work with Quality Management to ensure appropriate quality standards for the duration Start Up (or Maintenance, as applicable).Mentor colleagues as required.Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.May take a proactive role in developing long standing relationships with preferred Quintiles customers.Deliver presentations/training to clients, colleagues and professional bodies, as required.REQUIRED KNOWLEDGE, SKILLS AND ABILITIESGood negation and communication skills with ability to challengeGood interpersonal skills and strong team player;Proven ability to work through others to deliver results to the appropriate quality and timeline metrics on complex projectsThorough understanding of regulated clinical trial environment and knowledge of drug development processDemonstrated proficiency in using systems and technology to achieve work objectivesGood regulatory and/or technical writing skillsGood knowledge and ability to apply GCP/ICH and applicable regulatory guidelines and applicable regulatory guidelinesGood leadership skills, with ability to motivate, coach and mentorGood organizational and planning skillsProven ability to exercise independent judgment taking calculated risks when making decisionsGood presentation skillsGood understanding of study financial managementAbility to establish and maintain effective working relationships with co-workers, managers and sponsorsProven ability to work on multiple projects balancing competing priorities QualificationsMINIMUM REQUIRED EDUCATION AND EXPERIENCEBachelor's degree in life sciences or related field, with 5 years relevant experience in a scientific or clinical environment including demonstrable experience in acting as the main regional lead in studies or equivalent combination of education, training and experience.PHYSICAL REQUIREMENTSExtensive use of keyboard requiring repetitive motion of fingers.Extensive use of telephone and face-to-face communication requiring accurate perception of speech.Regular sitting for extended periods of time
Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 5-10

Requirements

Clinical Research | Drug Regulation | Research Scientist
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