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 www.pharmavise.com

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 - 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 veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

Job Type: Full-time

Pay: $58.00 - $60.00 per hour

Expected hours: 40 per week

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Application Question(s):

• Part of our recruitment process is to vet, validate, and verify. Are you okay with providing your credentials, signing your Right to Represent document and Resume Verification Form as needed?
• If not, are you willing to relocate to Minnesota on your own terms? (Write N/A if not applicable)
• We must fill this position urgently. Can you start immediately?
• How many years of labeling experience do you have?
• What tools are you familiar with?
• Do you have labeling project management experience?
• Do you have a strong knowledge of labeling procedures, requirements, and quality system?
• How many years of experience do you have working for the medical device industry?

Education:

• Bachelor's (Required)

Location:

• Minneapolis, MN (Required)

Work Location: Remote