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Global Labeling Lead

Employer
i-Pharm Consulting
Location
England
Salary
Negotiable
Start date
27 Jan 2020
Closing date
10 Feb 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

The Global Labeling Lead (GLL) has overall accountability for the initial creation and relevant updates to labeling documents for their assigned products. This includes guiding the Labeling Team to develop and maintain Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized Procedures, and their associated Patient Labeling Documents.

The GLL will guide and advise the Labeling Team on internal labeling guidances and policies and will raise awareness of important factors to consider when revising the label. The GLL will keep up to date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and will advise the Labeling Team on the application of these labeling principles. The GLL will also be knowledgeable on key labeling requirements worldwide, in order to ensure that CDS updates may be implemented globally. The GLL will review the downstream impact of CDS updates on Local Product Documents (LPD) and ensure that downstream impact on LPDs is considered during Labeling Team discussions.

The GLL provides project management to the Labeling Team throughout the entire process, from the decision to update a CDS/USPI/SPC through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal and external deadlines.

The GLL serves as the GLM primary point of contact for Labeling Teams and will provide day-to-day direction to Labeling Operations Managers so that labeling and decision documents can be prepared and managed appropriately throughout processes and systems.

Qualifications

Education:

  • Life sciences, pharmacy graduate or equivalent.
  • Advanced academic qualifications/degree such as PhD an advantage but not essential.

Experience and Attributes:

  • 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); experiences of review and implications of the CDS 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.
  • 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 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 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.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Company info
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
United Kingdom

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