Regulatory

  • location: Northbrook, IL
  • type: Contract
  • salary: $27 - $60 per hour

job description

Chat with me now! - https://flashrecruit.com/jobs/300830

Job Title: Regulatory Affairs Resource I

Position Description

  • Primary position is to work within the Regulatory Affairs labeling group to provide proofreading support for labeling components. Secondary position is within the Regulatory Affairs labeling group developing product prescribing information and packaging content and artwork.
  • Primarily responsible for proofreading of pharmaceutical package inserts and labels ensuring accuracy and consistency against content and redline files. Proofreading includes label documents for submission to FDA and other health authorities in both English and Spanish. May also have some responsibility for development, implementation, and change control of new and revised labeling for assigned products and areas within the Americas region. Ensures compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. Researches government initiatives related to labeling and packaging, and assures that adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners.

Position Responsibilities

  • Able to proofread a variety of labeling for spelling, grammar, design and format consistency. Ability to pay close attention to detail.
  • Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate).
  • Organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files.
  • Leads labeling development teams for regional product launches and ensures that all labeling 5. Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines.
  • Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution.
  • Collaborates with Regulatory Affairs Liaisons on submission and implementation strategy for labeling.
  • Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures.
  • Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply.
  • Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration. Keep management apprised of critical issues which may impact the success of the organization.
  • This position has the potential to independently interface with local and global team members from the Associate level to the Senior Director level. The position reports to the Associate Director, Regulatory Affairs Labeling.

Position Requirements

Required

  • Four year college degree preferred but not required
  • 2 years working in pharmaceutical product labeling required.
  • At least 6 years previous industry experience; 3 in RA.
  • Direct pharmaceutical labeling development experience required with demonstrated proficiency in managing change control.
  • Proven proficiency with relevant FDA/ICH and other local health authority regulations & guidelines for labeling development, implementation, and compliance requirements, and applies understanding to business situations
  • Proven effectiveness with stakeholders in the labeling system from content development through commercial supply
  • Must be able to effectively influence peers and others both inside and outside the organization and maintain effective working relationships.
  • Strong organizational skills and high level of attention to detail, with the ability to coordinate multiple large and diverse projects simultaneously.
  • Excellent written and verbal communication skills (native and non-native English speakers).
  • High integrity with respect to maintenance of proprietary, confidential information

Preferred

  • Bachelor's degree in scientific discipline; advanced degree preferred
  • Scientific knowledge in chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity.
  • Resource should have experience using Docuproof as this is the tool they will use. Docuproof is an electronic proofreading technology.
  • Interpersonal and communication skills is a must
  • Experience with Outlook and Microsoft is needed.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/300830

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