IN-Senior Associate_Functional Expert â Pharma Domain_Intelligent Automation_Advisory_Noida
IN-Senior Associate_Functional Expert â Pharma Domain_Intelligent Automation_Advisory_Noida
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Job Description
Line of Service
AdvisoryIndustry/Sector
Not ApplicableSpecialism
OperationsManagement Level
Senior AssociateJob Description & Summary
At PwC our people in data and analytics engineering focus on leveraging advanced technologies and techniques to design and develop robust data solutions for clients. They play a crucial role in transforming raw data into actionable insights enabling informed decision-making and driving business growth.Those in intelligent automation at PwC will focus on conducting process mining designing next generation small- and large-scale automation solutions and implementing intelligent process automation robotic process automation and digital workflow solutions to help clients achieve operational efficiencies and reduce costs.
Responsibilities:
End-to-End Pharma Lifecycle Expertise:
Provide functional expertise across the full lifecycle of pharmaceutical products fromdiscoveryandpreclinical research throughclinical trialsregulatory approvalsmanufacturingdistributionlogisticssales & marketingQMSandpharmacovigilance.
Strategic Guidance:
Collaborate with senior leadership to ensure the integration of best practices compliance standards and industry trends across the product lifecycle. Support the business in implementing effective strategies and operational efficiencies.
Cross-functional collaboration:
Work closely with cross-functional teams includingR&Dregulatory affairsmanufacturingsupply chainsales & marketing andsafetydepartments to ensure seamless operations and product delivery.
Compliacne & Regulatory Expertise:
Provide in-depth knowledge of regulatory requirements (FDA EMA ICH etc.) and ensure that products meet all regulatory standards throughout their lifecycle. Guide teams on regulatory documentation submissions and approvals.
Clinical Trials & Data Management:
Oversee the design and execution of clinical trials ensuring they adhere to GxP (Good Clinical Practice) and ICH standards. Support the management of clinical trial data ensuring compliance with regulatory bodies.
Manufacturing & Supply Chain Optimization:
Ensure manufacturing processes are aligned with quality standards and regulations. Collaborate with manufacturing teams to optimize production reduce costs and enhance operational efficiency.
Pharma covigilance & Drug Safety:
Lead pharmacovigilance efforts ensuring the monitoring of drug safety throughout the lifecycle including post-market surveillance adverse event reporting and risk management.
Sales & Marketing Support:
Provide insights and functional expertise to the sales and marketing teams ensuring alignment with regulatory standards and successful product launches. Guide the development of promotional materials advertising and product claims.
Training & Knowledge Sharing:
Develop training materials and conduct workshops to enhance functional knowledge across teams. Act as a mentor and advisor to junior staff members.
Continuous Improvement:
Evaluate current practices and identify opportunities for continuous improvement in processes systems and tools. Propose and implement changes to enhance operational efficiency and compliance.
Mandatory skill sets:
Educational Background:
Bachelors degree in a scientific or related field (e.g. Pharmaceutical Sciences Life Sciences or Chemistry).
Experience:
At least4-6 yearsof hands-on experience in the pharmaceutical industry with extensive knowledge of the end-to-end product lifecycle.
Experience indrug discoveryclinical trialsregulatory affairsmanufacturingdistributionsales & marketing andpharmacovigilance.
Deep understanding ofregulatory frameworkssuch asFDA EMA andICH guidelines.
Proven track record of supporting cross-functional teams in bringing products to market.
Skills & Competencies:
Stronganalyticalandproblem-solvingskills with the ability to make data-driven decisions.
Exceptionalcommunicationskills to interact with internal teams stakeholders and regulatory bodies.
Strong project management skills with the ability to prioritize and handle multiple initiatives.
Experience working with pharmaceutical systems (LIMS ERP QMS etc.) is a plus.
Certifications (Optional):
Certifications such asCertified Pharmaceutical Industry Professional (CPIP)orProject Management Professional (PMP)would be advantageous.
Preferred skill sets:
Experience working withglobal teamsand managing products across international markets.
Exposure todigital transformationin the pharmaceutical industry including automation and data analytics tools.
Years of experience :
4-7 years
Education Qualification:
MBA MCA
Education (if blank degree and/or field of study not specified)
Degrees/Field of Study required: Bachelor of Engineering Master of Business AdministrationDegrees/Field of Study preferred:Certifications (if blank certifications not specified)
Required Skills
Pharmacy MarketingOptional Skills
Accepting Feedback Accepting Feedback Active Listening Agile Methodology Analytical Thinking Automation Algorithms Automation Engineering Automation Framework Design and Development Automation Programming Automation Solutions Automation Studio Automation System Efficiency Blue Prism Business Analysis Business Performance Management Business Process Analysis Business Process Automation (BPA) Business Transformation Business Value Optimization C Programming Language Cognitive Automation Communication Conducting Discovery Configuration Management (CM) Continuous Process Improvement 36 moreDesired Languages (If blank desired languages not specified)
Travel Requirements
Not SpecifiedAvailable for Work Visa Sponsorship
NoGovernment Clearance Required
NoJob Posting End Date
Required Experience:
Senior IC
Employment Type
Full-Time
