Job for M.Pharm, M.Sc, B.Pharm as Consultant at Infosys

Infosys is committed to the communities in which it operates. This has led to the creation of Infosys Foundation to support the underprivileged sections of society. A not-for-profit initiative aimed at fulfilling the social responsibility of Infosys Ltd., the Infosys Foundation creates opportunities and strives towards a more equitable society.  Established in 1996, the Infosys Foundation supports programs in the areas of education, rural development, healthcare, arts and culture, and destitute care. Its mission is to work in remote regions of several states in India.

Post : Consultant

Job Description 
• Get to the heart of customer issues, diagnose problem areas, design innovative solutions and facilitate deployment resulting in client delight.,
• Lead small projects.,
• Contribute to unit-level and organizational initiatives.,
• Adherence to the organizational guidelines and processes

Candidate Profile
Minimum 5 years of relevant experience is required. ,Desired Skills & Experience,Required,
• Bachelor’s/Masters/PhD degree in Biotechnology / Medicine / Life sciences / Pharmaceutical Sciences / Engineering or equivalent. ,
• 6- 10 years of experience in Pharmaceutical R&D Clinical domain with good expertise in Clinical Trials related areas like Clinical Trial Management, Clinical Data Management ,or ,Excellent knowledge in Pharmaceutical R&D Regulatory domain with expertise in regulatory submission process including Hands on exposure the submission requirements and types of submission and associated regulations pertaining to different health authorities, especially FDA and EMA, Good knowledge of business processes in EVMPD/IDMP /Product License Tracking (small molecules/Med devices/biologics)/CMC,
• Must have performed requirement analysis, use case modeling, etc. from a business analysis/consulting standpoint.,
• Must be able to translate business requirements into well-formed technical and system requirements,
• Experience in Business analysis methodologies and processes ,
• Strong business consulting skills associated with complex system implementation spanning over 12-18 months.,
• Strong communication skills, planning and Co-ordination skills, Stakeholder management, Good Knowledge of SDLC processes.,Preferred,
• Experience in one or more of the following skills,
•  End to end Clinical trial management process and related applications. ,
• Experience on clinical reporting (internal, FDA) during study start to closeout phases. ,
• Knowledge of Clinical Data Management processes with knowledge of Clinical DataWarehouse,
• Familiarity with Good Clinical Practices, Good Documentation practices, Clinical Trial Quality & Compliance. ,
• Good Knowledge of Study life cycle activities (Study Protocols /study design for IRT and EDC Studies), various study milestones, clinical trial regulatory reports and other metrics reports at study level /site level. ,Or,
• Experience in,
• Regulatory submission systems like content authoring, submission, product registration tracking, EVMPD/IDMP.,
• Labeling process and systems,
• Experience with modeling business processes, data flows, and workflow processes depicting relationships between Clinical data entities. ,
• Strong business consulting skills associated with complex IT system implementation spanning over 12-18 months.,
• Experience and desire to work in a management consulting environment that requires regular travel ,
• A basic knowledge writing custom queries in SQL or PL/SQL is needed for data extraction and validation.,
• Experience in the full System Development Life Cycle (SDLC) on a variety of technologies and platforms.,Location of posting shall be driven as per business needs.

Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc
Location : Hyderabad,Pune
Industry Type : Pharma
Functional Area : Clinical Trial & Data Management, Pharma Domain
End Date : 25th December, 2018

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