Who are we?
We Are PRA.
We are 16,000+ employees strong, operating in more than 90 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We are getting lifesaving drugs into the hands those who need them most.
Who are you?
Relationship-Builder You are helpful, respectful, approachable, team and service-oriented, building strong working relationships and a positive work environment; who maintains an exceptional client service mindset.
Results Orientation You effectively execute on plans, drive for results and take accountability for outcomes. Persevere and do not give up easily in challenging situations. Recognize and capitalize on opportunities. Take full accountability for achieving (or failing to achieve) desired results.
Problem Solving You take an organized and logical approach to thinking through problems and complex issues. Simplify complexity by breaking down issues into manageable parts. Look beyond the obvious to get at root causes. Develop insight into problems, issues and situations.
Adaptability You have the ability to re-direct personal efforts in response to changing circumstances. Are receptive to new ideas and new ways of doing things. Effectively prioritize according to competing demands and shifting objectives. Can navigate through uncertainty and knows when to change course.
Continuous Learning You demonstrate a desire and capacity to expand expertise develop new skills and grow professionally. Seek and take ownership of opportunities to learn, acquire new knowledge and deepen technical expertise. Take advantage of formal and informal developmental opportunities. Take on challenging work assignments that lead to professional growth.
What you will be doing: US Labeling Operations works within Regulatory Labeling works in accordance with all current regulatory requirements, for all aspects of labeling document development, management, and implementation (e.g, creation, revision, proofreading, format to FDA requirements [i.e. SPL], obtaining approvals, implementation, tracking and maintenance). You will have the responsibility for activities associated with the creation, management, and implementation of US labeling, in conjunction with the Global Labeling Lead and Regulatory Lead. You will also be responsible for guidance to Labeling Associate for labeling projects supported by that role.
Functions as a Subject Matter Expert (SME) for US regulatory labeling requirements. Identifies and provides regulatory labeling guidance to ensure that labeling development processes conform to all applicable regulatory, legal and company requirements.
Based on knowledge of regional regulatory requirements for the US, provides labeling expertise to the Global Labeling Lead (GLL) and Regulatory Lead (RL) for labeling development, management and review. Controls the consistency of labeling content across a product family.
May facilitate regional labeling working groups for US packaging artwork. May participate in label working groups for prescribing information.
Manages all labeling development activities for new product introductions and for updates of current product labeling, with minimal supervision, while working with external vendors to execute the final deliverable.
Ensures the US labeling content meets current CCDS.
Initiates the creation or revision of artwork for labeling, by communicating with Graphics Responsible groups.
Ensures that change control processes are followed to maintain accuracy of change during revisions/versioning of documents.
Manages pending labeling implementation timing, including new submissions, pending submissions, planned submissions and changes in approved timelines through formalized systems and processes.
Supports GLL and/or RL for submission and implementation strategy, to ensure that all applicable agreed timelines are met.
Establishes and manages cross-functional relationships to ensure control and continuous improvement of labeling programs to meet business needs and regulatory requirements
Ensures that tracking of development and implementation activities are documented and maintained.
Initiates and/or implements procedures, processes, or programs that result in improvements, corrective actions, problem prevention, or cost-savings
Supports US Labeling Operations Manager, as needed
Evaluate risks and appropriately escalate issues to management.
Participate in training Labeling Associates on relevant labeling policies and procedures, as needed
What you need to have:
Bachelor's degree (BS/BSc or BA), preferably in a scientific or health-related discipline
Atleast 10 years' relevant experience including 2 years formal people management experience or equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above.
All employees must read, write and speak fluent English and host country language.
Significant knowledge of FDA current regulation/guidance, particularly those related to labeling and demonstrated ability to apply regulations, guidelines and regulatory processes to provide regulatory guidance
Strong understanding of industry practice, scientific principles and regulatory/quality systems in the drug development process.
Demonstrated project management skills, attention to detail and ability to meet timelines.
Demonstrated problem-solving skills with ability to generate proposed alternative solutions for to Manager.
Ability to communicate effectively in team and cross-functional setting.
Excellent oral and written communication skills.
Demonstrated negotiation and interpersonal skills.
Ability to work in a team environment but can function equally well independently
Ability to travel up to 10%
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.
PRA Health Sciences