Durham,
NC
US
Posted: 07/08/2022
2022-07-08
2022-09-10
Job Number: 21047134
Job Description
MANAGER-LABELING STRATEGY AND DEVELOPMENT
DURHAM, NC
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
ALPHA'S REQUIREMENT #22-02076
W2 ONLY MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
Share This Job:
Login to save this search and get notified of similar positions.