Technical Writer / Labeling Specialist (Medical Device)

Primary Talent Partners has an exciting 6 month contract opening for a Technical Writer / Labeling Specialist with a large Medical Device client of ours in Northridge, CA.
Pay Rate: $37.85 to $42.85 per hour
Top Skills:

1. Previous CAPA management/support in another company (familiarity with CAPA quality structure/requirements)
2. Root Cause Analysis
3. Process analysis/development

Education: Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0-1 years of relevant experience.

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 decisionmaking.
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.

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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