Posição: Mid-Senior level

Tipo de empregos: Full-time

Loading ...

Conteúdo do emprego

Hobson Prior are looking for a Labelling Manager to join a brilliant pharmaceutical organisation on a permanent basis. Our client is focused on increasing their knowledge in healing those with iron deficiencies.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities
  • For this role, you will be responsible for offering scientific & regulatory labelling input into creation and maintenance of CCDS, in collaboration with other GRA functional groups and any other CMRST departmental representatives.
  • Supervise and deliver guidance within the company on developing global labelling requirements. Recognise and guarantee suitable responses or adaptations that are required by evolving regulatory requirements.
  • Counsel junior colleagues within the GRA Labelling group to build knowledge on labelling and packaging issues and requirements.
  • Perform internal training and awareness course on labelling.
  • Confirm that local labels worldwide are in alignment with CCDS & national requirements, in partnership with product & regional responsible GRA contacts, and that applicable deviations are documented and followed.
  • Work alongside the product teams to classify and outline labelling-related issues, improve wording, clarity and use of consistent standards across products & portfolios.
  • Direct the regulatory labelling database and ensure label related information is made available to stakeholders (external/internal) appropriately (GLS, Trackwise, planning & tracking tools, notification lists).
  • Manage any communication with affiliates, internal stakeholders and partners to certify label compliance, including update notifications and maintenance of distribution lists.
  • Alongside the product teams, present labelling-related issues to appropriate approval and governance committees (CMRST, DSB, DRRB), including coordination of the Q&A with the Health Authorities as per the procedures in place.
  • Run translations and QC of PI documents during linguistic review between HAs and local countries.
Key Skills
  • Able to converse clearly and accurately, both orally and in writing.
  • Have a creative, solution-oriented work approach; takes a proactive approach to identifying support, information flows and processes.
Requirements
  • Has the ability to work efficiently with a wide variety of personnel across diverse teams and functions within the corporation as well as at external partner companies.
  • Procure a leading role with the ability to independently resolve issues suitably, and in a customer-oriented manner.
  • Meet timelines, or proactively recognises potential delays and acts to reduce them.
  • Distribute first-rate, precise documents and work products according to agree upon processes.
Apply Now

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
Loading ...
Loading ...

Data limite: 05-05-2024

Clique para aplicar para o candidato livre

Aplicar

Loading ...
Loading ...

EMPREGOS SEMELHANTES

Loading ...
Loading ...