Senior Associate_Functional Expert - Pharma Domain

4 - 7 years

10 - 14 Lacs

Posted:4 months ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

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 decisionmaking and driving business growth. Those in intelligent automation at PwC will focus on conducting process mining, designing next generation small and largescale automation solutions, and implementing intelligent process automation, robotic process automation and digital workflow solutions to help clients achieve operational efficiencies and reduce costs. EndtoEnd Pharma Lifecycle Expertise Provide functional expertise across the full lifecycle of pharmaceutical products, from discovery and preclinical research , through clinical trials , regulatory approvals , manufacturing , distribution , logistics , sales marketing , QMS and pharmacovigilance . 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. Crossfunctional collaboration Work closely with crossfunctional teams, including RD , regulatory affairs , manufacturing , supply chain , sales marketing , and safety departments, to ensure seamless operations and product delivery. Compliacne Regulatory Expertise Provide indepth 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 postmarket 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 Bachelor s degree in a scientific or related field (e.g., Pharmaceutical Sciences, Life Sciences, or Chemistry). Experience At least 46 years of handson experience in the pharmaceutical industry, with extensive knowledge of the endtoend product lifecycle. Experience in drug discovery , clinical trials , regulatory affairs , manufacturing , distribution , sales marketing , and pharmacovigilance . Deep understanding of regulatory frameworks such as FDA, EMA , and ICH guidelines . Proven track record of supporting crossfunctional teams in bringing products to market. Skills Competencies Strong analytical and problemsolving skills, with the ability to make datadriven decisions. Exceptional communication skills 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 as Certified Pharmaceutical Industry Professional (CPIP) or Project Management Professional (PMP) would be advantageous . Preferred skill sets Experience working with global teams and managing products across international markets. Exposure to digital transformation in the pharmaceutical industry, including automation and data analytics tools. Education Qualification B.tech , M.tech , MBA, MCA Education Degrees/Field of Study required Bachelor of Engineering, Master of Business Administration Degrees/Field of Study preferred Certifications (if blank, certifications not specified) Required Skills Pharmacy Marketing Optional 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

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PwC Service Delivery Center

IT Services and IT Consulting

New York NY

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