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Job Details

Senior Medical Writer

Company: Hydrogen Group
Location: England
Reference: JO-1701-900375
Closing Date: 30 Jan 17
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

The Hydrogen Group is hiring for an experienced Senior Medical Writer who is ambitious, accountable and with strong leadership skills, in order to take on complex projects and complete them successfully. This is a great opportunity for an individual to contribute their expertise to facilitate and assist a growing medical writing team at a global pharmaceutical services organisation.The role comes with an attractive salary.

Requirements:

The Hydrogen Group is hiring for an experienced Senior Medical Writer who is ambitious, accountable and with strong leadership skills, in order to take on complex projects and complete them successfully. This is a great opportunity for an individual to contribute their expertise to facilitate and assist a growing medical writing team at a global pharmaceutical services organisation.

The role comes with an attractive salary. The position is based in one of the company’s major global hubs located England. More information on this can be given upon request. Please contact Elizabeth De Pontes on D +44 (0)20 7002 0263 or M +44 (0)78 3738 8807 or alternatively email: elizabethpontes@hydrogengroup.com
Senior Medical Writer

As a Senior Medical Writer you will have the opportunity to gain experience on a number of strategic and operational on specific projects whilst assisting the organisation to maximise the success of their products’ development and lifecycle maintenance.

Responsibilities:

* Act as Regulatory representative on different projects by providing your clinical expertise and knowledge.
* Responsible for identifying the required documentation and any content to deliver successful reports according to the clients’ programs.
* Responsible for draft or review effectively regulatory and clinical documents (clinical study reports, investigator brochures, clinical study protocols/amendments, clinical summaries and clinical overview).
* Understand the organisation’s system in order to instruct new professionals.
* Support when needed to complete the writing of regulatory documents that contribute on the negotiation with Regulatory bodies such as PIP’s or Orphan Drug Designation applications.

Requirements:

* Minimum of 5 years of experience in the Medical Writing field is required
* Experience reviewing and preparing clinical documents meeting the EMA and FDA regulatory guidance
* Solid understanding of the CFR, FDA/ICH guidelines
* Fluent English required (oral and written).
* Excellent analytical and communication skills both verbal and written.

If you would like to discuss this role please contact Elizabeth De Pontes on D +44 (0)20 7002 0263 or M +44 (0)78 3738 8807 alternatively email: elizabethpontes@hydrogengroup.com
The Hydrogen Group values confidentiality and will not share your details without your informed consent.

Apply for this job: Senior Medical Writer

Contact Information:

Address:  Head Office
30 Eastcheap London
EC3M 1HD
England
Tel:  +44 (0) 207 002 0000

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