: Regulatory Labeling Core Content Sr. Associate (JP8097)
Thousand Oaks, CA
: 12 months with likely extensions
Job posting date
Remote until COVID-19 restrictions are lifted.
3 Key Consulting is hiring a Regulatory Labeling Core Content Sr. Associate
for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
Minimum Qualification Criteria:
- 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 the client’s 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.
Preferred 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.
- 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.
Background - Final Product Platform Governance (FPPG) Business Process:
- 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.
To better serve patients, the client 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.
Top Must have Skill Sets:
- Knowledge of regulatory labeling development.
- FDA Engagement experience.
- Combination product development experience
- Biotech or Pharma experience
Under the direction of the RL CCL (Primary responsibilities):
Employee Value Proposition:
- 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 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.
FPPG - Final Product Platform Governance
- Lack of medical device, pharmaceutical or biotech experience.
- lack of cross functional experience.
4 interviewer, 1 phone screen followed by video interview.
We invite qualified candidates to send your resume to firstname.lastname@example.org. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com
. You are welcome to also share this posting with anyone you think might be interested in applying for this role.