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Labeling Consultant

4 months ago

GondrecourtleChâteau, Grand Est, United States Pharmavise Full time
Job Description
Job Role: Labeling Consultant

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at

Our Fortune 500 Client has an exciting opportunity for a Labeling Consultant.

Job Summary:

Creates/revises product literature and labeling. Works closely with project teams to ensure labeling content is developed per, and compliant to, all applicable procedures. Develops schedules and ensures labeling deliverables are executed to them while maintaining a high standard of quality. Resident expert and primary point of contact for product literature and labeling.

Responsibilities and Job Requirements:
  • Coordinates all product labeling deliverables (will vary by project), including labels, IFUs/DFUs, and carton and pouch artwork, etc.
  • Coordinates creation/revision of deliverables from project initiation through completion.
  • Assesses the scope of each project and works with team members and project management to create labeling plans and secure necessary resources.
  • Develops deliverable schedules and establishes milestones for tracking progress. Ensures on-time completion of deliverables, and communicates project status, challenges, and successes on a regular basis to project and functional management.
  • Understands and coordinates/monitors completion of key dependencies from other functions.
  • Monitors and, when necessary, works with functional and project management to address issues that could negatively impact schedule or quality.
  • Leads cross functional teams through content development for labeling deliverables by managing the drafts, collecting input and source data, making changes, tracking revisions, and keeping teams on schedule.
  • Fosters and improves content consistency across labeling.
  • Facilitates team reviews of labeling deliverables to ensure content is accurate, complete, fully compliant to relevant regulations and requirements, and meets the needs of the customer.
  • Coordinates desktop publishing and labeling artwork generation.
  • Coordinates implementation/release activities of labeling deliverables.
  • Manages content changes (and mitigates their impact on schedule and consistency) by pushing teams to focus on accuracy and completeness.
  • Implements product labeling via Boston Scientific's Document Control System.
  • Leverages expertise with labeling procedures, requirements, and quality system to ensure all deliverables are fully compliant and free of errors.
  • Identifies and implements opportunities for continuous improvement and innovation.
Quality Systems Requirements:

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System.
Qualifications:
  • Requires expanded conceptual and technical and/or functional knowledge in own job function
  • Broadens capabilities in applying concepts in job function
  • Demonstrates working knowledge of business and industry practices and company processes to accomplish own work
  • Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions.
  • Works under general direction from more senior level roles/manager
  • Impacts quality of own work and the work of others on the team; works within guidelines and policies
  • Explains factual information of limited complexity to others in straightforward situations
  • Organizes, presents and explains data/ information, primarily to internal audiences
Requirements:
  • 4 years+ direct labeling or technical writing experience
  • Bachelor's degree
  • Medical Electrical Equipment/ Capital Equipment experience
  • Adobe Suite Creative Suite experience strongly preferred
  • MS Office and MS Project experience strongly preferred
  • Project Management experience
Other Details:
  • Contract Length: 12 months (with potential to increase to 2 years)
  • Work Set up: Hybrid at Arden Hills, MN
  • Start date: ASAP
EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected ve