layiq

/la·yiq/adjective

worthy; deserving; fitting; suitable.

A role, opportunity, or path that merits attention, time, and pursuit.

LAYIQ - Labeling Compliance Senior Associate at Par Health

Education & Experience
Minimum Bachelor’s degree or equivalent experience.
Minimum of –4-6 years of labeling experience in the pharmaceutical industry.
Broad based pharmaceutical industry knowledge (Regulatory, Manufacturing, Quality Assurance, Supply Chain, Marketing)
Knowledg e
Strong knowledge of regulations/guidelines governing labeling of pharmaceutical products is required, for both brand and generic drugs.
Working knowledge of FDA electronic submission documents required.
Strong knowledge and understanding of current Good Manufacturing Practices and Standard Operation Procedures.
Experience using an electronic document management system (e.g. Veeva Vault) is required.
Experience with developing structured product labeling (SPL) and using SPL software is required.
Experience using an electronic labeling management system is preferred.
Skills & Abilitie s
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules their tasks; Develops realistic action plans.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules their tasks; Develops realistic action plans.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Labeling Compliance Senior Associate

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