Global Labelling Strategist

LifelancerBoston, Massachusetts, United States

30+ days ago

Job type

Full-time

Remote

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Job description

Job Title : Global Labelling Strategist

Job Location : Boston, MA, USA

Job Location Type : Remote

Job Contract Type : Full-time

Job Seniority Level : Mid-Senior level

argenx is a clinical-stage biopharmaceutical company that is creating and developing a pipeline of differentiated antibody therapeutics. Our unique antibody engineering technologies combined with the complementary expertise of our people enabled us to build a clinical-stage portfolio of novel product candidates – tailored from discovery through development to address patient needs.

Purpose Of The Position

Within regulatory affairs and in cross-functional teams, lead the labeling development of one asset, supervise Target Product Label initiative across argenx portfolio and, when needed, contribute to the labeling strategy of other assets.

Key Accountabilities / Responsibilities

Lead labeling development strategy in cross functional teams based on target product profile, competitor review, regulations, development data and present it to the development governance for endorsement
Create and maintain target product profile for one asset from phase 2 until registrational phase and for new indication of registered asset(s)
Create and maintain Core Company Data Sheet and, in partnership with Labeling Operation Manager, global labeling implementation plan
Support US affiliate in USPI creation and maintenance
Coordinate global labeling impact assessment of HA or internal queries of local label update in post-marketing, involving :
Labeling working group (LWG) - Cross functional team which members are identified in function of topics among Development team, Project team, Pharmacovigilance, Regulatory leads, Medical affairs, Commercial, Legal representatives, Intellectual property, CMC, supply chain.
Global labeling committee (GLC) to endorse LWG proposal
Create and maintain processes related to labeling development activity

Desired Skills And Experience

Prior experience in biologic products, medical devices, combined products

Prior experience in clinical development and / or regulatory affairs environment

Strong understanding of labeling end-to-end process and interfaces between clinical development, medical affairs, Pharmacovigilance, Regulatory, Quality and Supply Chain to ensure compliance

Knowledge of US, EU, Japanese labeling templates and labeling sections of eCTD dossier

Knowledge of health authority websites (in particular FDA, EMA websites) to retrieve label precedents and labeling regulations

Knowledge of electronic tools such as Dr evidence / Doc label, Adobe Acrobat Pro, Regulatory information management systems, Electronic Document Management System (e.g. Veeva Vault), other tools for labeling quality control (Text Verification Tool).

Detail oriented and well organized

Good oral and written English language skills

Active listening, understanding constraints from other discipline

Critical thinking : using logic and reasoning to identify the strength and weaknesses of alternative solutions, conclusions or approached to problems

Active learning : understanding the implications of new information for both current and future problem-solving and decision-making

Analytical skills : decision taking based on facts and figures rather than on assumptions

Team player who seeks to help and learn from colleagues

High learning attitude and adaptability

At least Bachelor’s Degree

At least 5 years of experience in global labeling strategy (development and post-marketing)

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