Labeling Compliance Senior Associate

Regulatory Affairs Chestnut Ridge, New York


Description

Job Summary - a concise overview of the job

The Labeling Compliance Senior Associate is responsible for the overall development and coordination of new and approved labeling components. Draft, create, and finalize labeling components for commercial use.  

Assist in the final release of printed labeling.

 

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

Graphics & Technical Skills

 

 

 

§  Work closely with Graphics lead regarding all in-house artwork.

§  Assist with the design and update of labeling component artwork for NDA, ANDA and subsequent Post Approval submissions (Annual Report, CBE and Prior Approval Supplements).

§  Compile and Distribute new and updated labeling PDFs for internal and external sources.

§  Interface with internal departments, print vendor and Third Party partners on artwork requirements and implement required in-house and customer driven artwork development and revisions for labeling components.

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

30%

 Labeling Initiation & Changes

 

 

 

 

§  Assist with executing RLD updates, Safety updates, FDA requests and non FDA labeling updates.

§  With Supervision, monitor FDA websites for all Labeling updates for approved/marketed products; create and disseminate appropriate documentation to implement changes.

§  Interact and communicate with Contract Manufacturers, Project Management and other pertinent functional areas, on applicable project timelines.

§  Guide the timely review/approval of new and revised product labeling for drug products driven by FDA implementation dates.

30%

Labeling Review

§  Proofread and review in-house labeling components for all Par sites, Contract Manufacturers and special projects utilizing electronic proofreading tools.

§  Review regulatory documentation pertaining to NDA, ANDA and post approval submissions for labeling revision verification. 

30%

Collaboration

§  Monitor graphic development of relative labeling components for all generic products.

§  Provide support to internal departments, customers and vendors pertaining to labeling requests, inquiries, issues and responses.

§  Other miscellaneous duties and job responsibilities to support labeling activities.

10%

Total

100%

 

Qualifications

Education & Experience

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

§  Bachelor’s degree in a scientific or other health related discipline or an equivalent overall knowledge based on previous work experience.

§  At least 5 years’ experience in pharmaceutical labeling compliance and/or operations.


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.

§  Proficient with computer systems and software applications (Windows & Mac).

§  Working knowledge of Adobe Creative Suite (Illustrator, InDesign, Acrobat Pro,

        Photo shop).

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.

§  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.

§  Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

§   Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

 

 

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, not in open area, that is conducive to job responsibilities.

 

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.