Pfizer UK Industrial Trainee Scheme 2016/2017

Worldwide Regulatory Operations

Publishing & Product License Support
Publishing & Product License Support - Industrial Trainee
ID
DEPARTMENT OVERVIEW
Publishing and Product License Support (PPLS) consists of two global teams and sits within the Worldwide
Regulatory Operations (WRO) group of Pfizer.
The Publishing team spans 5 locations globally, working closely with Submissions Management to
publish, validate and archive all of Pfizers regulatory submissions and correspondence to Health
Authorities. These submissions are published in a number of different formats including eCTD
(electronic Common Technical Document), NeES (Non eCTD Electronic Submission) and Paper.
The Product License Support team spans 11 locations globally and is made up of 6 different
functions. The team supports New Drug Application (NDA), Annual Report compilation, authoring
of labeling summary sections for NDA AR and PADERs, US Drug Listing and Establishment
Registration transactions, and Structured Product Labeling (SPL) Creation. In addition, the team
sources a large portion of module 1 content for international markets, provides verification of
presence and consistency of required investigator related documents in the electronic Trial
Master File (TMF), facilitating the release of Pfizer sponsored investigational medicinal product.
The team also supports the maintenance of the EEA Article 57(2) pharmacovigilance regulation.
ROLE PURPOSE
This role will support regional and global non-drug project PPLS specific initiatives, of varying complexity,
for which Worldwide Regulatory Operations is either an owner or a major stakeholder.
The PPLS industrial trainee will support the evaluation of existing processes, help facilitate the collective
strategic direction of a more effective future state and contribute to the implementation of new or revised
processes that are driven by external guidelines, technologies and business strategy.
The role has a strong continuous improvement and project management focus alongside exposure to key
regulatory operations stakeholders within the business.

Pfizer UK Industrial Trainee Scheme 2016/2017

MAJOR DUTIES AND RESPONSIBILITIES

Support business analysis and project management practices to help to ensure the success of a broad
variety of initiatives and projects

Issue resolution for prescribed projects

Contribute to technical solutions through partnership with internal and external colleagues.

Process development, decision making, and change management in the context of WRO

Support (or contribute to) cross-functional teams as appropriate

Development and maintenance of documented procedures and guidelines as necessary

PERSON SPECIFICATION
Type of person we are looking for, in relation to Skills, Knowledge and Motivation:

Excellent verbal, written and presentation skills

Ability to work effectively in a team environment
Confidence to liaise with Pfizer personnel at all levels
Ability to generate creative and innovative ideas

Enthusiasm and pro-active approach

Technical Awareness