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AstraZeneca · 3 days ago

Associate Director, Global Labelling Strategy

Gaithersburg, MD

Full-time

Onsite

Lead/Staff, Director/Executive

$135K/yr - $203K/yr

2+ years exp

AstraZeneca is a leading pharmaceutical company dedicated to improving healthcare through innovative medicines. They are seeking an Associate Director for Global Labelling Strategy to provide regulatory strategic labelling expertise and lead the development of labelling strategies for marketed and pipeline products in the Respiratory and Immunology therapy area.

BiopharmaBiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

Comp. & Benefits

Responsibilities

Lead the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio

Lead the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality Review of Documents (QRD), US Prescribing Information (PI), and Instructions for Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling

Lead the development of labelling negotiation strategies, anticipating health authority perspectives

Provide labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance

Provide clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and propose mitigations

Evaluate, interpret and communicate global regulations and trends on labelling and any business impact these might have on product labelling

Lead the development of Target Product Labelling (TPL) documents

Assist in the development of labelling documents, policies, procedures and SOPs

Ensure that the labelling process is followed through the lifecycle of the product

Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs

Qualification

Regulatory AffairsLabelling StrategyScientific BackgroundPharmaceutical ExperienceLabelling RegulationsCommunication SkillsAttention to DetailStrategic ThinkingRelationship BuildingNegotiation Skills

Required

Bachelor's degree in Science or related discipline

2 - 4 years of pharmaceutical experience, including regulatory and labelling experience

Ability to assimilate clinical and scientific information and present it in a concise manner

Knowledge of labelling regulations and guidance

Excellent verbal and written communication skills

Keen attention to detail and accuracy

Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

Must demonstrate competencies in building relationships, negotiation skills, critical information seeking, rational persuasion, interpersonal awareness

Preferred

Advanced academic training is highly desirable (PharmD, PhD)

Benefits

Short-term incentive bonus opportunity

Equity-based long-term incentive program (salaried roles)

Retirement contribution (hourly roles)

Commission payment eligibility (sales roles)

Qualified retirement program [401(k) plan]

Paid vacation and holidays

Paid leaves

Health benefits including medical, prescription drug, dental, and vision coverage

Company

AstraZeneca

Glassdoor4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10001+ employees