(US - REMOTE) Global Labeling Lead Consultant - CCDS, SmPC, USPIs
REMOTEPosted 30+ days ago
Job summary
Job post source
This job is from a recruiting firm hiring for a separate company, as ClinChoice is described as a global CRO providing services to pharma clients rather than the direct employer of the role.
Job overview
The Global Labeling Lead Consultant role involves leading pharmaceutical labeling operations, ensuring compliance and quality in labeling documents like CCDS, SmPC, and USPIs, impacting regulatory adherence and client satisfaction.
Responsibilities and impact
The consultant will lead and guide the labeling team, manage labeling projects, ensure compliance with FDA, EMA, and ICH guidelines, collaborate cross-functionally, provide expert advice to clients, and contribute to business growth and strategic initiatives.
Experience and skills
Candidates need a bachelor's degree in a scientific field, 7+ years in pharmaceutical labeling operations, strong regulatory knowledge, project management skills, leadership abilities, and proficiency in Microsoft Office; advanced degrees are a plus.
Career development
ClinChoice emphasizes professional development through continuous training and career growth opportunities within a global CRO environment.
Work environment and culture
ClinChoice promotes a supportive, inclusive, and diverse culture focused on quality, employee development, and low turnover, valuing employees as key assets.
Company information
ClinChoice is a global full-service CRO with over 28 years of experience, 4000+ professionals, and operations across Americas, Europe, and Asia-Pacific, specializing in clinical development and functional solutions for pharma and biotech.
Team overview
The candidate will join a client-facing labeling team within ClinChoice, working closely with cross-functional teams including Regulatory Affairs, Clinical Operations, and Quality Assurance.
Job location and travel
This is a remote position based in the US, offering flexibility in work location.
Application process
Applicants submit a CV, receive an acknowledgment, and if qualified, proceed to a phone interview; due to volume, only successful candidates are contacted further.
Unique job features
The role offers the unique opportunity to work directly for a pharma client while benefiting from the security and career opportunities of a global CRO, with leadership responsibilities and strategic influence in labeling operations.
Company overview
ClinChoice is a global clinical research organization that provides comprehensive clinical development and consulting services to the pharmaceutical, biotechnology, and medical device industries. They make money by offering services such as clinical trial management, regulatory consulting, data management, and biostatistics to support the development and approval of new medical products. Founded in 1995, ClinChoice has grown through strategic acquisitions and partnerships, expanding its global footprint and capabilities to deliver high-quality, cost-effective solutions for their clients.
How to land this job
Position your resume to highlight your extensive experience in pharmaceutical labeling operations, emphasizing leadership in managing CCDS, SmPC, and USPIs development and updates.
Focus on showcasing your strong knowledge of FDA, EMA, and ICH regulatory guidelines, your project management skills, and your ability to lead cross-functional teams and liaise with stakeholders effectively.
Apply through multiple channels including ClinChoice's official corporate website and LinkedIn job postings to maximize your application visibility and chances of success.
Connect with current ClinChoice employees in the labeling or regulatory affairs divisions on LinkedIn; start conversations by complimenting recent ClinChoice projects or asking about their experience working on global labeling strategies.
Optimize your resume for ATS by incorporating keywords from the job description such as 'pharmaceutical labeling,' 'CCDS,' 'regulatory compliance,' 'project management,' and 'cross-functional collaboration' to ensure it passes automated screenings.
Use Jennie Johnson's Power Apply feature to automate your tailored applications, identify multiple application portals, and find relevant ClinChoice contacts to network with, allowing you to focus more on interview preparation and skill enhancement.
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