Manager-Labeling Strategy And Development

Durham, NC

Posted: 07/08/2022 Job Number: 21047134

Job Description

Required Skills:
  • Life sciences degree and relevant experience or PhD or equivalent relevant experience.
  • Relevant experience includes regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic.
  • Scientific Regulatory Writing the ability to produce written regulatory scientific communications with clarity, accuracy, and rigor.
  • Data analysis skills.
  • Therapeutic / Product Knowledge.
  • Will have some knowledge of therapeutic area(s), particularly the vaccines area, and be developing a sound knowledge of a product portfolio.
  • Regulatory Knowledge.
  • Basic understanding of policy and processes relating to management of prescriber, patient, and pack information in the company.
  • Some appreciation of the purpose and scope of pharmaceutical regulation related to product information and maintains an awareness of new external guidelines/policies pertaining to product information.

Project Description:
  • In this role the individual is responsible to their line function for the timely production of documentation .
  • To manage the development and maintenance of the Global Product Information for Prescribing/Patient/Packaging Information .
  • To support regional and country product information (prescriber and patient), primarily in the US .
  • Development and maintenance of the Global Product Information (PI), in conjunction with functional experts .
  • Authoring of the patient information in the Global Patient Leaflet (GPL) .
  • Development and maintenance of the US prescribing information .
  • Generation of responses to regulatory agency questions related to prescriber and patient information in accordance with company policies and procedures.
  • The development and maintenance of the Global PI, together with support of local product information requires leadership of cross-functional teams and the ability to work with individuals at all levels of the business.
  • Participation in the development of Development Core Safety Information (DCSI).
  • Development of Global PI for PLEs, with appropriate mentoring.
  • Independent management of the Global PI for marketed products, including presentation of items at Global Labelling Committees.
  • Authoring the Global Patient Leaflet (GPL) and Global Packaging Component (GPC) of the Global PI.
  • Management of the development and maintenance of US prescribing information documents throughout the product lifecycle.
  • Active membership of the Regulatory Matrix Team and submission writing process .
  • Awareness and application of relevant pharmaceutical regulation and new guidelines/policies relevant to product information.
  • Supporting Local Operating Companies during implementation of Global PI wording.
  • Authoring responses to labelling questions from regulatory agencies.
  • Authoring Competitive Labelling Assessments (CLA) .
  • Authoring relevant sections of the Periodic Safety Update Report.
  • Participation in other projects and activities, such as contributing to the implementation of changes to processes within GRA Labelling.
  • Participation in mandatory training and completion of the training records.

This 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Jim: jim@alphaconsulting.Com


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