SPL Specialist

3 weeks ago


Bengaluru, Karnataka, India Genpact Full time

Genpact is a global professional services firm delivering outcomes that shape the future. Our people are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting Applications for SPL Specialist

Genpact invites applications for the role of SPL Specialist. This position requires a strong candidate with experience in Structured Product Labeling (SPL) Preparation and Listing for USFDA. The successful candidate will be responsible for creation and management of FDA-required Structured Product Labeling (SPL) documents, including labeling, bulk drug listing, establishment registration, and blanket no change certifications.

Key Responsibilities:
  • Creation and management of FDA-required Structured Product Labeling (SPL) documents.
  • Preparation of new SPL as per client requirements.
  • Updation of existing SPL as per client requirements.
  • Formatting of SPL documents as per Final Patient Information Leaflet.
  • Ensuring correct consistency in alignment of style/hierarchy.
  • Ensuring proper spaces and line break.
  • Quality control of SPL to ensure correctness of Link/References/Table/Figure/Sections Hyperlinked TOC's, Registration Mark, Hard Space, Numbered/Bulleted List, Blank Space, and Spell Check.
  • Successful submission of SPL listing to FDA without any validation issue/rejection.
Requirements:
  • M.Pharma/B.Pharma or any other relevant life science graduate.
  • Good proofreading and typing skill and understanding of client requirements.
  • Labelling, eCTD, submissions, documents.
Preferred Qualifications:
  • Efficient in handling tools such as SPL tool, Adobe Acrobat, and MS Word.
  • Ability in conducting quality review of documents by peers.
  • Expert in resolving queries of peers and troubleshooting technical issues if encountered.
  • Ability to adapt in a changing environment and flexibility towards change in processes and procedures.
  • Ability to work effectively in a collaborative team environment.


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