Labeling Specification Specialist

Planet Pharma; Minneapolis (MN); On-site; USD 85,000 - 120,000; Full time

Job summary

Planet Pharma is seeking a labeling specialist to manage the creation, review, and reproduction of text for labeling medical products. You will ensure compliance with medical, legal, and regulatory standards across labeling proofs and promotional materials.

The role requires practical knowledge in a regulated environment, familiarity with PLM systems and labeling tools, and experience with Illustrator and Loftware Spectrum. University degree and 2+ years relevant experience preferred.

Qualifications

• Requires University Degree and minimum of 2 years of relevant experience.
• Experience with medical product labeling and regulatory considerations.

Responsibilities

• Creates, reviews, and reproduces text required for labeling medical products.
• Ensures labeling, art, film, and plate proofs meet medical, legal, and regulatory requirements.
• Monitors changes in labeling regulations in the US and abroad.
• Reviews promotional material to ensure data support and consistency with the application.
• Monitors, evaluates and recommends improvements to labeling processes, quality, and tools.

Skills

Medical labeling experience

Education

University degree

Tools

Enovia/Windchill PLM

Adobe Illustrator

Loftware Spectrum Labeling

Job description

• Experience with Medical Package labeling

2. Experience releasing specs/drawings in a PLM system (Enovia/Windchill)

3. Adobe Illustrator experience

4. Loftware Spectrum Labeling systems (preferred)

Responsibilities may include the following and other duties may be assigned. Creates, reviews, and reproduces text required for labeling medical products. Ensures that labeling, art, film, and plate proofs meet all medical, legal, and regulatory requirements. Monitors changes in labeling regulations in the US and/or abroad. Reviews promotional and commercial communication material and ensures that it is supported by the data and consistent with the application. Monitor, evaluate and recommend improvements to labeling processes, quality, systems tools and/or policies.

SPECIALIST CAREER STREAM:

Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS

Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.

Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience:

Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience