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Senior Labeling Lead

Employer
Labcorp
Location
Netherlands
Salary
Competitive
Start date
15 Apr 2021
Closing date
14 May 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details


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Education/Qualifications:
  • Life sciences, pharmacy graduate or equivalent.
  • Advanced academic qualifications/degree such as PhD an advantage but not essential.
  • Minimum 7 to8 yrs of relevant experience in Strategic/Global labeling
Experience:
Significant 'hands on' registration experience associated with development, maintenance and commercialization activities within Regulatory Affairs (Human Medicinal Products); Perspective from HQ, Country office and/or Regional Regulatory Strategy (at a global/multi-national pharmaceutical environment) necessary. Experience at the country level important and advantageous.
  • Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS), Core Safety Information (CSI); experiences of review and implications of the CDS/CSI an advantage.
  • Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
  • Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
  • Demonstrated ability to develop strong and positive working relationships across multiple cultures and locations.
  • Understanding of regulatory authority philosophy and expectations.
  • Knowledge of global/regional regulatory guidelines and requirements important.
  • Excellent written and verbal communication skills essential.
  • Complete Fluency in English Language.
  • Proven strength in logical, analytical and writing ability essential.
  • Demonstrated project management skills and attention to detail required.
  • Proven ability to negotiate, influence and problem solve.


Technical Skills

  • Knowledge of global/regional regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels across the regions.
  • Demonstrated knowledge and understanding of company Core Data Sheets, Core Safety Information documents and the dynamics of Labeling Team purpose and objectives.
  • Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
  • Fluency in English language important; multi-language skills are advantageous.
  • Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication. Demonstrated ability to influence and negotiate where necessary, across a highly matrixed team.
  • Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
  • Ability to interact effectively with all levels/roles of project team members.
  • Handled Development product labeling updates

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
 Maidenhead
SL6 3QH
United Kingdom
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