Medical Writing Manager, Cambridge, UK

Medical Writing Manager required for leading Pharmaceutical company.

Working as a Medical Writing Manager, you will be required to ensure that all medical writing documents are prepared for Drug Development programmes within the company. These documents need to be prepared according to rigorous, objective and informative medical writing procedures and processes.

You will lead the Medical Writing activities for the US, European or other regulatory submissions as assigned. You will need to ensure that documents for clinical trials are prepared, reviewed, and approved in a timely and accurate manner such that the data presented will withstand examination by regulatory bodies.

You will need to be knowledgeable of Electronic Document Management System (EDMS) to support the full use of the EDMS for all products across the Company’s therapy areas within the Group. You will need to have a Medical Writing ability in Early Development Studies with strong Scientific experience in Medical Writing.

Requirements for the position:

Life science degree, preferably with a higher degree (MSc or PhD).

Significant experience of medical writing, preferably with experience in the following therapy areas:

– Oncology,

– Endocrinology,

– Neuromuscular Disorders,

– Primary Care, or

A demonstrated ability to quickly assimilate new therapeutic areas.

Good understanding of GCP, the Clinical development process and of ICH guidelines.

Ability to mange complex projects and coordinate production of multiple documents.

Ability to plan and prioritise own and other’s workload and interact with staff of differing disciplines.

If you would like to know more about the role please call Hendre at 01438 743 047. Alternatively apply by sending your CV to hmoolman@ckclinical.co.uk, quoting the reference number 16015 in your email. If you want us to help you with other jobs do not hesitate to give Hendre a call on 01438 743 047.

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