Pharmaceutical Labeling Specialist

Temporary

PHARMACEUTICAL LABELING SPECIALIST

TAMPA, FL

100% REMOTE Position

2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.

Pay ranges between $48.40 - $51.47 per hour.

Required Skills :

  • Bachelor's degree - or Master's Degree, preferred in sciences with 2 years of direct Labeling Experience in a Regulated environment, or 3 years with a combination of Labeling Experience and Pharmaceutical experience.
  • Basic knowledge of labeling regulations and HA approval structure outside of assigned region or countries, including but not limited to USA and EU.
  • Must possess an excellent command of language (English) and professional knowledge of medical terms,
  • Proficiency in standard office technology, including Microsoft Suite, Outlook Mail / Calendar; willing to learn additional applications as needed.
  • Experience working on multi-disciplinary teams and projects.
  • Good knowledge of rigorous pharmaceutical and / or scientific documentation practices and change control processes (e.

g., revision control).

  • US military experience will be considered towards industry experience requirements.
  • Good communication and organizational skills and a meticulous eye for detail.
  • Good understanding of pharmaceutical or medical terminology.
  • The ability to work as part of a team that supports global functions with a high level of professionalism.
  • Knowledge / understanding of another language in a region supported (e.g., Spanish, Arabic, Chinese).

Project Description :

  • Works under the guidance of the International Labeling Operations Lead or with Senior Specialists.
  • Manages external requests for country specific labeling information (e.g., medical content, pharmaceutical properties) from various sources or reference documents.
  • Notifies appropriate groups or changes or recent source / reference labeling approvals.
  • Prepares country-specific labeling in support of safe and appropriate use of the Client products for in-scope countries;

maintains country specific translation master copy to meet labeling responsibilities.

  • Prepares, tracks, maintains and reviews required labeling documents (e.g., physician's label, patient insert, carton, label, blister, tenders) using Text verification Tools, and additional software or process tools to maintain change history for all labeling documents.
  • Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
  • Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
  • Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
  • Maintains an understanding of regulatory labeling requirements of assigned region or countries.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren : [email protected]

ALPHA'S REQUIREMENT #23-01191

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

LI-LG1

LI-Remote

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100% REMOTE Position

2 years of direct labeling experience in a regulated environment, or 3 years with a combination of labeling experience and pharmaceutical experience.

Pay ranges between $48.40 - $51.47 per hour.

Required Skills :

  • Bachelor's degree - or Master's Degree, preferred in sciences with 2 years of direct Labeling Experience in a Regulated environment, or 3 years with a combination of Labeling Experience and Pharmaceutical experience.
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  • Manages external requests for country specific labeling information (e.g., medical content, pharmaceutical properties) from various sources or reference documents.
  • Notifies appropriate groups or changes or recent source / reference labeling approvals.
  • Prepares country-specific labeling in support of safe and appropriate use of the Client products for in-scope countries;

maintains country specific translation master copy to meet labeling responsibilities.

  • Prepares, tracks, maintains and reviews required labeling documents (e.g., physician's label, patient insert, carton, label, blister, tenders) using Text verification Tools, and additional software or process tools to maintain change history for all labeling documents.
  • Initiates and approves final printed artwork on behalf of the country when needed for artwork changes and assists with timely implementation of the updated artwork in the market.
  • Notifies the artwork studio team, manufacturing, Global Planning and Supply representatives as needed of upcoming changes to labeling and provide guidance as to when the changes need to be implemented based on information supplied by each market affected.
  • Supports the end-to-end process to minimize the risk and associated costs of a significant error occurring in the final labeling preparation that results in a product recall due to labeling.
  • Maintains an understanding of regulatory labeling requirements of assigned region or countries.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren : [email protected]

ALPHA'S REQUIREMENT #23-01191

MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

LI-LG1

LI-Remote

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Opportunities with Amplity offer competitive compensation and dependent on the opportunity could include a comprehensive benefits package and 401K benefits.

To learn more about us, visit our website at amplity.com or our social media pages, linkedin.com / company / amplity-health and twitter.com / amplityhealth.

CELEBRATING DIVERSE PERSPECTIVES

We passionately champion a culture of belonging, with transparent company practices that drive diversity, equity, and inclusion.

Our commitment to inclusion is core to who we are. We welcome people with diverse backgrounds and perspective who ignite curiosity and challenge the status quo.

As a provider of services across 6 continents, our team is as diverse as the clients we serve and the countries we work in.

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