The Product License Support, Senior Associate , reporting through the US Compliance Team, will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations. Product License Support Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.
The PLS Senior Associate for US Compliance is responsible for delivering all (A)NDA, BLA, and PMA annual reporting and drug listing activities required by the US Food and Drug Administration (FDA) to maintain active applications across Pfizer's entire portfolio (all business units). Our regulatory activities are driven by FDA guidance as well as internal policies and procedures focused on the US market.
PLS Senior Associate for US Compliance will focus on Annual Report includes compiling, authoring, and submission readiness of each submission.The PLS Senior Associate will also author Periodic Adverse Event Reports (PADER) labeling contributions.Drug listing responsibilities include NDC assignments, label publishing to Pfizer websites, creation and management of SPL (Structured Product Labeling), establishment and device registrations, and FDA User Fee activities (i.e.: PDUFA, GDUFA, BsUFA, and MDUFA).
The scope of work also expands into preparing and completing metadata submission to the GUDID Database to comply with FDA's UDI (Unique Device Identification) regulations, managing call for contributions for various Safety Aggregate reports, engaging the emerging markets. Responsibilities:
- Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR 314.81.
- Continuous Improvement of selected processes relating to human health submissions and selected drug and non-drug specific projects and related activities e.g. Drug listing and Establishment registrations,
- Delivery of Product License Support Portfolio in a timely and quality manner.
- Contributes to the completion of project tasks and/or milestones
- Organizes own work to meet project task deadlines
- Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
- Has fundamental knowledge of the principles and concepts of the discipline.
- Applies technical skills to achieve assigned tasks
- Contributes to the completion of routine Work Team related tasks.
- Uses established procedures and methodologies.
- Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
- Applies fundamental knowledge of the relevant regulatory industry and local business environment.
- Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
- Makes decisions that require choosing between limited options to resolve problems basic in their complexity
- Performs work in a structured environment under direction from supervisor
- Decisions impact own work and have limited effect on projects.
- Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
- Exercises judgment to complete assigned tasks and has significant reliance on supervisor
- Works in a structured environment under direct supervision
- Uses established procedures to perform assigned tasks
- Asks for guidance from other colleagues
- Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
- Communicates straightforward information, asks questions and checks for understanding
- Participates and contributes as a team member
- Is responsible for certain team deliverables.
- Implementation of solutions through interaction with other team members, and key contributors across sites, ensuring ability to maintain compliance with assigned processes and continuously improve on those processes
- Participation on global/local teams to complete assignments and tasks within a specific task force/project. Contributes to the completion of moderately complex projects.
- Liaison with internal stakeholders for issues regarding standards and processes, and drives resolution of these.
- Utilization support of electronic technologies for submissions and tracking of documentation
- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables) within a Work Team.
- Applies technical skills and Work Team knowledge to achieve assigned work on projects/assignments
- May act as a technical resource within own Work Team
- Utilizes regulatory expertise, experience and technical skills to deliver on moderately complex tasks to support submissions to the Regulatory Authorities
- Has a strong understanding of the relevant regulatory industry and local business environment.
- Has strong understanding of clinical, regulatory and/or other relative stakeholder groups.
- Works under general supervision. Performs assignments using established procedures and general instruction on the process and desired outcome
- Uses a variety of communication tools and techniques to explain difficult issues and works to establish consensus
- Undergraduate degree plus relevant experience as below, or
- Demonstrated fluency with regulatory submissions publishing and understanding of application of technologies.
- Demonstrated ability to function autonomously in a matrix environment.
- Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems
- Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
- Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.
- Functional/Technical Skills - has the functional and technical knowledge and skills to do the job at a high level of accomplishment
- Acts Decisively - makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
- Seizes Accountability -will stand up and be counted; doesn't shirk personal responsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment
- Change Agile - can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
- Peer Relationships- can quickly find common ground and solve problems for the good of all; can represent his/her own interests and yet be fair to other groups; can solve problems with peers with a minimum of noise; is seen as a team player and is cooperative; easily gains trust and support of peers; encourages collaboration; can be candid with peers
- Influencing - Uses a range of effective communication styles and creates and inclusive environment with internal/external stakeholders to deliver goals and promote quality; uses diplomacy and tact and can diffuse high-tension situations comfortably.
- Demonstrated knowledge of CFR as it relates to specific post-market submissions
- Demonstrated knowledge of/experience with Pfizer Commercial Portfolio
- Ability to communicate information and analyses to a variety of audiences both verbal and written format
- Demonstration of processes, tools and techniques for planning and monitoring multiple projects to established deadlines.
- Demonstrated coordination of activities in a highly regulated environment
- Proven aptitude in project management and logistics
- Demonstration of experience working in a challenging customer service environment
- Proven experience managing or delivering through others in a team environment
- Demonstrated attention to detail
- Understanding of applicable filing regulatory guidelines and fluency regarding order and presentation of regional and national regulatory dossiers
- Formal training in technical tools
- Knowledge of drug development process
Work Location Assignment:Flexible
Relocation assistance may be available based on business needs and/or eligibility.Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.