Groton, CT, USA
2 days ago
IT - Consultant | LifeSciences | Clinical Trials, Compliance & Safety
Job Seekers, Please send resumes to resumes@hireitpeople.com

Must Have Skills (Top 3 technical skills only)*:

4 to 10 years of experience in life sciences research and development area and good understanding of key business processes around Commercial, Clinical, Regulatory & Safety. Experience with modeling business processes, data flows, and workflow processes depicting relationships between data entities. Good Knowledge of SDLC processes.Strong business consulting skills associated with medium complex IT system implementation spanning over 6 to12month

Nice to have skills (Top 2 only):

Good knowledge of business processes in EVMPDIDMP Product License Tracking (small moleculesMed devices biologics.Good Knowledge and Labeling process and systems . Good exposure to regulatory document content management systems and submission authoring assembly of eCTD Chemistry Manufacturing Control (CMC) including hands on exposure the submission requirements and types of submission and associated regulations pertaining to different health authorities, especially FDA and EMA

Detailed Job Description:

He will be a key player in the consulting team that helps discover and define the problem statement, evaluates the solution options and makes recommendations. You will create detailed functional design architecture and process artifacts and support the validation from a SME perspective and involve in user acceptance. You will also support knowledge transfer with the objective of providing valueadding consulting solutions that enable our clients to meet the changing needs of the global landscape.

Minimum years of experience*: 5+

Certifications Needed: No

Top 3 responsibilities you would expect the Subcon to shoulder and execute*:

Be a key player in the consulting team that helps discover and define the problem statement, evaluates the solution options and makes recommendations. You will create detailed functional design architecture and process artifacts and support the validation from a SME perspective and involve in user acceptance. You will also support knowledge transfer with the objective of providing valueadding consulting solutions that enable our clients to meet the changing needs of the global landscape.

Interview Process (Is face to face required?) No

Does this position require Visa independent candidates only? No

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