Top 3 Must Have Skill Sets:
Knowledge of regulatory labeling development
FDA Engagement experience
Combination product development experience
Biotech or Pharma experience
Day to Day Responsibilities:
Under the direction of the RL CCL (Primary responsibilities)
Support platform label working group, schedule/facilitate meetings, take meeting minutes, prepare meeting materials to develop platform content for instructions for use
Support creation/maintenance of platform Instructions For Use (IFU), assess ongoing product IFU changes against platform to determine impact on platform IFU.
Gather pertinent information and / or documentation to support fit-to-platform and change impact assessment Support implementation of FPPG endorsed platform changes to applicable product IFUs as needed.
Engage with RL-related project leads that are endorsed to proceed through the FPPG process, in concert with Commercial and Operations CCLs
Support non-RL related projects endorsed to proceed through the FPPG process, in concert with Commercial and Operations CCLs
Support Platform Leads, and Commercial and Operations CCLs during the development of Platform guidelines and minimum requirements.
Author business process and project management documentation (e.g. process roadmaps, risk registries, project charters, project plans, etc…)
Under the direction of the Ops CCL (Secondary responsibilities, as needed)
Schedule and facilitate meetings supporting the development of Ops-focused core content & minimum requirements for brand-specific content
Schedule and facilitate meetings with brand teams to develop product specific Ops-focused core content implementation strategies
The Regulatory Labeling (RL) Core Content Sr. Associate will support the Operations (Ops) and RL Core Content Leads (CCLs) in the new Final Product Platform Governance (FPPG) business process. The Regulatory Labeling CC Sr. Associate will be accountable for completing assigned / delegated core content deliverables on-time and in a manner commensurate with quality standards.
The knowledge and skillset necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Qualification Criteria -
Doctorate’s degree and one (1) year of Pharmaceutical or Biotechnology Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs experience; or
Master’s degree and three (3) years of Pharmaceutical or Biotechnology CMC Regulatory Affairs experience; or
Bachelor’s degree and five (5) years of Pharmaceutical or Biotechnology CMC Regulatory Affairs experience
Preferred Qualification Criteria -
Minimum educational qualifications and 3 or more years of experience working in Pharmaceutical or Biotech supporting global labeling or regulatory affairs.
Experience in developing/maintaining global labeling documents (e.g. Instructions for Use (IFU), carton/container label)
Experience in drug delivery device development, manufacturing, or supply chain management
High level of proficiency in Word, Excel, PowerPoint, Microsoft Project
Ability to build professional networks, foster collaboration, work effectively within cross-functional teams, and consistently complete assigned deliverables on-time
Demonstrated strong oral and written communication skills
Demonstrated strong interpersonal skills
Demonstrated time management and decision-making skills
Demonstrated Ability to manage in a highly fluid, interactive, matrix environment
Desired Competencies -
Knowledge of pharmaceutical or Biotechnology product development
Knowledge of Medical Device design and development
Drug product labeling requirements in the United States and European Union
Background - Final Product Platform Governance (FPPG) Business Process:
To better serve patients, instituted the FPPG business process to ensure its final product platforms (and components) are designed, developed, and implemented across its innovative therapeutic brands / franchises consistently and effectively. The FPPG business process establishes clear accountability and communication across functions responsible for design, development, and lifecycle management of final product platforms intended for clinical and commercial manufacture and distribution to patients and end users.
"This posting is for Contingent Worker, not an FTE"