Lead Consultant - Structured Product Labeling Specialist

Genpact

Bengaluru/Bangalore

Not disclosed

Work from Office

Full Time

Min. 2 years

Job Details

Job Description

[Lead Consultant], [SPL Specialist]!

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries 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 the role of [Lead Consultant], [SPL Specialist]!
This position requires a strong candidate with experience in Structured Product Labeling (SPL) Preparation and Listing for USFDA. This position will mainly focus on preparation, proofreading, formatting, and processing SPL to USFDA, with the responsibility of ensuring they follow client standards.
Responsibilities
Responsible for Creation and Management of FDA-required Structured Product Labeling (SPL) documents, e.g., Labeling, Bulk Drug Listing, Establishment Registration, Blanket No Change Certifications.
Responsible for Preparation of New SPL as per client requirements.
Responsible for Updation of Existing SPL as per client requirements.
Responsible for formatting of SPL documents as per Final Patient information leaflet.
Responsible for ensuring correct consistency in alignment of style/hierarchy.
Responsible for ensuring proper spaces and line break.
Responsible for quality control of SPL to ensure the correctness Link/References/Table/Figure/Sections Hyperlinked TOC’s, Registration Mark, Hard Space, Numbered/Bulleted List, Blank Space and Spell Check.
Responsible for successfully submission of SPL listing to FDA without any validation issue/rejection.
Should be well versed SPL preparation tool and should have basic knowledge of XML language.
Responsible for providing new ideas and workarounds within the team.
Responsible as a backup team lead as in when required.
Qualifications we seek in you!
Minimum Qualifications / Skills
• 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/ Skills
• 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 the technical issue 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.
Demonstrate a growth mindset and positive outlook in all work activities.
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.

Job role

Work location

Bangalore

Department

Healthcare / Doctor / Hospital Staff

Role / Category

Doctor

Employment type

Full Time

Shift

Day Shift

Job requirements

Experience

Min. 2 years

About company

Name

Genpact

Job posted by Genpact

Apply on company website