Manager, Labeling Operations

  • location: Cambridge, MA
  • type: Contract
  • salary: $85.54 - $100.64 per hour
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job description

Manager, Labeling Operations

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Cambridge, Massachusetts
job type: Contract
salary: $85.54 - 100.64 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Provide a support function to the RA product leads with prime responsibility for US products.
  • Subject Matter Expert (SME) for all matters relating to US product labeling artwork
  • Work with the Supply Chain team to help manage the packaging update process following approval, including progression of artwork via Artwork Management system (SAMs).
  • Review new packaging, primarily for US products, and complete all steps required to implement the packaging.
  • QC of labeling documents as identified by supervisor.
  • Regulatory assessment of changes impacting US artwork.
  • Assist US Product Leads with change controls where required.
  • Author and review Standard Operating Procedures, Best Business Practices.
  • Assist with EU changes impacting labeling, including QC proofreading and progression of artworks.
  • Reviewing and approving labeling artwork for approved products for US.
  • Liaison with US Strategy Product Leads/Specialists on product updates impacting labeling. Attendance at meetings with US supply chain logistics.
  • Attendance at meetings for US new product launches (as required by US Strategy Product Leads/Specialists).
  • Assist with EU artwork changes (where required).
  • Author and review standard operating procedures and associated documents relating to artwork/regulatory involvement with Supply Chain.
  • Dispatching revised product labeling to the different departments inside and outside of Regulatory (as appropriate with local requirements.)
  • QC of labeling documents where required.
 
qualifications:
  • At least 5-8 years experience in the pharmaceutical industry, specifically in Supply Chain, Regulatory or Packaging Design.
  • Expertise in US packaging regulations.
  • Awareness of the print industry and manufacturing techniques and how they impact packaging design.
  • Understanding of XML and Electronic Document Management Systems to a sufficient level to support labeling documentation.
  • US experience is strongly desired.
  • Excellent verbal and written communication skills; ability to communicate effectively to multiple levels in the organization with strong negotiation skills.
  • Excellent analytical and communication skills both verbal and written.
  • Strong attention to detail and accuracy is a must.
  • A self-starter who motivates, has tact, diplomacy, leadership skills and who has a flexible and positive approach.
  • Ability to manage complex projects and timelines in a matrix team environment.
  • Demonstrated ability to integrate planning efforts across departments to ensure organizational effectiveness.
  • Ability to cultivate internal and external relationships based on trust and respect in anticipation of future working relationships; demonstrated ability to proactively maximize relationships to enable successful collaboration; demonstrated ability to facilitate a beneficial resolution of conflict.
  • Proficient in business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
  • Strong interpersonal, managerial and organizational skills.
  • Provides input into proposed timelines for packaging implementation
  • Provides design and technical input into packaging formatting issues specific to US products
 
skills: Quality control, MS-WORD, MS-EXCEL, MS-Powerpoint, MS-Project, Regulatory Affairs Operations, Clinical Supply Chain
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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