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Thursday, July 8, 2010

Executive, Clinical Supply Documentation

esignationExecutive, Clinical Supply Documentation
Job DescriptionJob Purpose (State in one sentence the overall objective of the role)

Establishes the packaging documentation (including label design and randomization) for Investigational Medicinal Products for clinical studies (Phase I-IV) according to GMP, GCP and other regulations.

Major Activities (Describe 8 – 12 main activities)

• Receives clinical order (CPR) and study specific information (e.g. packaging design, batch allocation) from DSM Study Manager

• Complements data entry in the DSM Planning Tool for order scheduling

• Generates labels according to country-specific requirements (following a general setup) and gets approval from the DRA contacts in the involved Country Pharma Organizations and the DSM Study Manager

• Performs randomization, gets approval from BQA and sets up text for emergency codes

• Creates the packaging documentation for medication of individual studies according to predefined study design

• Ensures compliance with study specific and QA requirements

• Performs Line Unit Check of packaging documentation for clinical supplies

• Interacts with DSM Study Manager to assure timely delivery of documentation to printing and packaging site
Desired ProfileScientific Degree

Experience in Pharmaceutical Development, Clinical Development, Project Management or Supply Chain prefered.

Strong interpersonal skills

Good communication and negotiation skills

Ability to organize and manage multiple projects simultaniously

Ability to work in interdisciplinary and intercultural teams

Quality and team oriented
Experience2 - 4 Years
Industry TypePharma/ Biotech/Clinical Research
RoleClinical Research Associate/Scientist
Functional AreaHealthcare, Medical, R&D
EducationUG - B.Pharma - Pharmacy
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization, Biology
LocationHyderabad / Secunderabad
KeywordsClinical trial documentation,clinical research.
Novartis Healthcare Pvt Ltd 
Website     Apply online


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