Labeling Operations Specialist

This is a fully remote position, open to applicants in United States, +2 more states.

📋 Description

• Offer operational assistance for the initial development and revisions of labeling documents, including CDS, USPI, SPC, and related patient labeling materials.

• Create clean and marked PDF and MS Word versions, ensuring documents are appropriately bookmarked.

• Manage document workflows through the corporate document repository.

• Complete documents following quality control protocols.

• Utilize labeling tracking systems and conduct system data quality audits.

• Employ text verification and proofreading tools.

• Inform internal stakeholders when labeling documents are accessible.

• Aggregate labeling versions and feedback from reviewers and Regulatory Authorities.

• Develop comparison tables for discussions within the labeling team.

• Revise and format labeling documents to align with templates such as QRD and PLR.

• Update and oversee the CDS log while managing document statuses in the document management system.

• Establish review and approval objectives, monitor timelines, and follow up with Labeling Team members.

• Generate SPLs for USPIs and collaborate with key Subject Matter Experts (SMEs).

• Revise associated labeling documents for similar product categories, dosage forms, and generics.

• Offer shadowing opportunities for junior Labeling Operations Managers.

• Ensure adherence to submission standards, policies, procedures, SOPs, and regulatory requirements.

• Monitor labeling projects according to established procedures and systems.

• Raise issues to the Global Labeling Lead and relevant stakeholders.

• Collaborate as a team member under general supervision, following established protocols.

⛳️ Requirements

• A Bachelor’s degree in a science or life sciences is required.

• 2-4 years of experience in a regulated environment is necessary.

• Experience in pharmaceutical labeling is preferred.

• Familiarity with global/regional regulatory guidelines and requirements is essential.

• Complete proficiency in English is required.

• Exceptional written and verbal communication skills are a must.

• Strong logical, analytical, and writing capabilities.

• Proven project management skills with a keen attention to detail.

• Ability to evaluate and manage project timelines effectively.

• Proficient in multitasking, prioritizing, and handling multiple projects.

• Capacity to proactively identify and resolve issues.

• Strong decision-making skills, including the ability to escalate issues to the Global Labeling Lead and stakeholders.

• Ability to operate under general supervision while following established procedures.

• Comfort working in ambiguous situations as part of a collaborative team.

• Ability to apply labeling regulatory guidance regarding formatting requirements.

• Competence in consolidating feedback from various sources.

• Excellent computer skills, particularly in Microsoft Word and similar applications.

• Capability to prepare documents that are ready for submission.

• Willingness to travel regionally or globally 5-10% of the time, including overnight stays as necessary.

🏝️ Benefits

• Option for remote work.

• Willingness to travel regionally or globally 5-10% of the time, including overnight stays as required by project needs and office location.

• Opportunity to join the Global Talent Network.

• Support for EEO and accommodations.