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Trainee Executive

1.00 to 2.00 Years   Chennai   24 Apr, 2021
PFIZER LIMITED
Job LocationChennai
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaTraining & Development
EmploymentTypeFull-time

Job Description

Support the review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents. The LOM, Associate will support non-complex products and projects.The LOM will provide operational support:

  • Consolidate labeling versions.
  • Consolidate comments from Labeling reviewers and Regulatory Authorities.
  • Prepare comparison tables for labeling team discussions.
  • Edit and format labeling documents- Ensure the document complies with the appropriate template (e.g., QRD, PLR).
  • Generate necessary renditions in GDMS (e.g., clean and marked PDF, clean and marked MS Word) and bookmark renditions as appropriate.
  • Facilitate workflow through corporate document repository, e.g., GDMS.
  • Finalize documents post QC (including update of GDMS document properties such as entry of PfLEET2 number, update of document title, update CDS cover page etc.).
  • Manage the document status in GDMS and notify internal stakeholders of the availability of labeling documents.
  • Order SPL for USPIs, check and upload to GDMS upon receipt, notify internal stakeholders of its availability (e.g., Regulatory, Drug Listing).
  • Update and maintain the CDS log.
  • Set clear targets for review and approval timelines for labeling documents using effective project management. Follow up with Labeling Team members to ensure timely review and approval deadlines are met.
Responsible for ensuring compliance to Company s submission standards, policies and procedures. Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained. Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.QualificationsEducation:
  • Bachelor s degree in a science or life sciences preferred or equivalent practical experience.
Experience and Attributes:
  • Excellent written and verbal communication skills essential.
  • Complete fluency in English Language.
  • Proven strength in logical, analytical and writing ability essential.
  • Demonstrated project management skills and attention to detail required.
  • Identifies and resolves problems in a proactive manner.
Project Management capability and organizational skills:
  • Ability to assess and manage project timelines.
  • Ability to multi-task, prioritize and manage multiple projects.
  • Ability to identify and resolve problems in a proactive manner.
  • Demonstrates appropriate decision making including issue escalation to the Global Labeling Lead (GLL) and other appropriate stakeholders.
Interpersonal and communication skills:
  • Ability to liaise with stakeholders using effective means of communication. Clear and effective written and verbal communication skills.
Technical Skills
  • Ability to apply labeling regulatory guidance on formatting requirements.
  • High attention to detail.
  • Ability to consolidate comments from multiple sources (e.g., emails, meeting minutes).
Systems and Document compilation skills, including:
  • Must have excellent computer skills and be proficient with Microsoft Word and similar applications.
Relocation support availablePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
microsoft wordcomputer skillsmanagement skillsproject managementregulatory affairscommunication skillsverbal communicationlegislative relations

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