Quality/Risk Management, Research & Development, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.
They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies.
May be assigned additional responsibilities as deemed necessary.
Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
Evaluate and communicate risks associated with CCDS content updates and implementation strategies
Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies
Assess competitor labeling - understand precedents & opportunities for Health Authority (HA) discussions
Understand implications for promotional and HTAs from local labeling
Support global HA interaction strategy to discuss key labeling elements
During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval
Contributes to the continuous improvement of the end-to-end labeling process
Solid understanding of global labeling regulatory requirements and industry practice
Excellent understanding of medical concepts and terminology
Strong written and oral communication skills
Strong computer skills including experience with Regulatory Information Management System (RIMS), EDMS, XML including SPL systems and MS Office: Word, Excel, PowerPoint, SharePoint and Outlook
Action oriented, customer focused, ability to manage workloads, set priorities, and ability to build effective teams. Must be able to deal with ambiguity.
Ability to generate problem solving innovative solutions Must deal with ambiguity and be action oriented.
Ability to recognize and escalate issues
Managing and Measuring Work
PhD/MS/DVM/MD/BS in life sciences, scientific, or engineering field.
5+ years of relevant experience in pharmaceutical regulatory/labeling environment. Role level to be determined by years and type of experience
Demonstrated ability to work with and manage people in a global, dynamic environment to deliver value-added results.
3 openings. Telecommuting is allowed.
Internal Number: 32273
About Pharmica Consulting
Since 2005, our project managers have been on the front lines of every aspect of the BioPharma industry’s changes. We know how to best manage your most important projects and also provide the BioPharma subject matter expertise that will help you get the best results.
Pharmica Project Managers are also seasoned pharma professionals with the subject matter expertise you need, so you know every PM will fit with your organization and every engagement will lead to consistent, reliable results. Pharmica Project Managers have the focus and flexibility to bring great ideas from the back of the napkin to the forefront of your organization.
We don’t just get things done, we have a good time along the way. Pharmica Project Managers are incredibly…normal. We relate. We’ll leave you with great results and great stories too.