Hub Labeling Manager (HLM)

Job title: Hub Labeling Manager (HLM)

Alternative job title:

Job location: Bucharest, RO

Experience requirements: No experience

Workfield requirements: Research & Development

Contract type: Temporary full-time

Sector: Pharmaceutical Sector

Locations: Romania - Bucuresti-Ilfov

Description

Position Purpose

The Hub Labeling manager (HLM) is primarily responsible for preparation of local product documents (LPDs) and their associated Local Language documents (LLDs) for theirassigned markets, updating the labeling documents on a timely basis according to internal SOPs and external regulatory requirements.

This role will act as a Subject Matter Expert (SME) on local, regional and multi-country

regulatory labelling requirements and participate in the sharing of intelligence. Additionally this role will support the use and development of current and new tools, technologies and processes to support global label development, submission and approval in respective countries.

Detailed job description is available in the Pfizer Careers Site searching for ID

Offer

CONTRACT TYPE: FIXED TERM 12 MONTHS

LAST DAY TO APPLY: JUNE

Required profile

Qualifications

* 1 year of pharmaceutical experience desired

* Experience of working within corporate systems and procedures

* Excellent project management skills, and ability to plan and prioritise, working within specific deadlines

* Written and verbal communications clear and effective, fluency in English essential

Technical Skills Requirements

* Knowledge of global/regional regulatory regulations and guidelines pertaining to labeling, and/or general regulatory background/experience, potentially gained in a country office environment, is preferred.

* Ability to understand, analyze and propose information into local labeling such as the LPD and Patient information and ability to logically review any impact on other sections of the same documentation.

Company introduction

Breakthroughs That Change Patients' Lives: Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our learn more, visit .