CK Group is recruiting for a Dossier Manager, to join a company in the Pharmaceutical industry, on a contract basis for 12 months.
Dossier Manager Role
* Monitor document receipts, follow up with contributors and manage translations (where applicable) for assigned submissions.
* Verify Suspected Unexpected Serious Adverse Reaction (SUSAR) arising from clinical trial, report to Regulatory Authority within agreed timeline to protect patient safety.
* Adhere to FDA regulations.
* Interface with multiple cultures and functions to recognize and exploit opportunities to use scale, cloning and repurposing dossiers for worldwide markets where feasible.
* Engage with Submission managers, Publishing leaders, business suppliers and regional representatives to agree on process and activities for opportunistic re-use of submission documentation for multiple national markets.
* Provide guidance and lead moderately complex submission and process improvement projects, making decisions independently.
Your Background
* Bachelor's degree in Pharmacy, Life Sciences, Business or Information Technology, or equivalent relevant professional experience will be considered.
* Relevant experience in electronic submissions build and publish within the Pharmaceutical Industry.
* Strong knowledge of the drug development process, regulatory sciences, and submission management & publishing.
* Proven aptitude in project management and logistics.
* Ability to work on multiple highly complex projects simultaneously.
Company Overview
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people every year.
Location
This role is based at our client's site in Sandwich.