Position Details :
Our client, a world-leading Pharmaceutical Company in Titusville, NJ is currently looking for a Process Modeling Specialist to join their expanding team.
Job Title : Process Modeling Specialist / Pharma Manufacturing / Hybrid Work
Duration : 12 months contract, extendable up to 24 months
Location : Titusville, NJ
Hybrid : 2-3 days / week Onsite
Note :
The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.
You may participate in the company group medical insurance plan
Job Description :
Responsible for design, planning, development and monitoring of clinical evaluation projects.
Interprets research results and evaluates the safety, marketability and medical usefulness of drug and product candidates.
Notes :
Role will be Hybrid in Titusville
Title of the role could be "Process Modeling Specialist "
Bachelor's degree
Will provide technical support for a manufacturing site
Use processes and modeling for the role
Must have data scientist exp
Work with data coming from systems
Use coding to transfer the data to better explain the process performance to leaders
Must have visualization exp
Must have Report Writing exp
Must have Statistic and Analytical exp (ex : ANOVA, Regression, etc)
Drug Product Manufacturing a big PLUS
Exp with R and / or Python
Duties & Responsibilities :
Monitors clinical evaluation projects, experimental protocols and patient forms.
Performs duties including protocol development, the maintenance of investigational sites, development of case report forms, informed consent, study drug projections and communication.
Documents and reviews steps needed for data collection, analysis.
Maintains correct standard operations, procedures and protocol.
Participates in interpretation results for phase 14 investigations in preparing for new drug application to the appropriate governmental body.
Adheres to clinical research guidelines and safety procedures.
Acquires knowledge and full understanding of clinical trials documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies.
Participates in verifying essential conditions that are necessary to determine the safety, efficacy, medical usefulness, and marketability of drug and product candidates.
Communicates detailed outcomes and results of research findings to customer and management.
Provides input to project planning and implementation activities.
Prepares relevant registrations, submissions and reports.
Serves as liaison to clinical sites and other vendors, as well as internal / external customers.
Prepares research status and findings reports for internal / external meetings, including investigator meetings and company sponsored events.
Work Experience :
Generally Requires 2-4 Years Work Experience
Education Required :
University / Bachelors Degree or Equivalent
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