Associate, Labeling Compliance & Graphics

Regulatory Affairs Chestnut Ridge, New York


Description

Job Summary - a concise overview of the job

 

The Associate, Labeling Compliance & Graphics is responsible for the creation, design and redesign of artwork for all labeling components and the maintenance of electronic artwork on designated server.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

U.S. Branded & Generic Product Portfolios

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Graphic

Design

§  Update labeling component artwork for NDA, ANDA and subsequent post approval submissions (Annual Reports, CBE and Prior Approval) for Regulatory Affairs for all Par sites.

§  Interface with internal departments, print vendors and outside contractors on artwork requirements and implement required in-house and customer driven artwork development and revisions for labeling components for Par Generics.

§  Provide PDFs for labeling components for internal and external sources.

§  Assure UPC guideline implementation on all labeling components.

§  Electronically transfer approval/rejection notification to print vendors & appropriate internal/external parties.

70 %

Documentation

§  Maintain website product literature files and provide electronic artwork for the Par’s online repository.

§  Support use of documentation systems/tools.

§  Maintain a Repository of all labeling documents, ensuring version control and document integrity between draft copy, FDA-submitted, and FDA-approved labels.

§  Maintain general filing as needed

 15 %

Collaboration

§  Support department with review of artwork, releases, masters and purchase orders when necessary.

§  Coordinate projects, timelines and due dates for in-house graphics projects, third party labeling and special assignments.

§  Assist and Support department head by providing the required pdf’s to close out Change Requests.

§  Assist Quality Assurance with GMP audits relative to graphics platform.

§  Support departmental personnel on projects.

 15 %

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  Bachelor’s degree in graphic or computer design or an equivalent overall knowledge based on previous work experience.

§  At least 2 years’ experience in graphic or computer design.  


Knowledge

Proficiency in a body of information required for the job   

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices.

§  Efficient with computer systems and software application (Windows, Adobe Creative Cloud Suite (InDesign, Illustrator, Acrobat & Photoshop), Apple Macintosh operating system).

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

§  Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.

§  Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.

§  Design - Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.

§  Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

§  Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

§  Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.

§  Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays or unexpected events.

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Cubicle that is appropriate for the job responsibilities.

§  Limited overnight travel may be required.

 

Disclaimer:  The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications.  Management reserves the right to change or modify such duties as required.