job details for:
Pharmaceutical - Medical Writer Jobs - North West, Cheshire

Pharmaceutical - Medical Writer Jobs - North West, Cheshire (Job Ref: WR/JOBS/25766-12101)

Job Description :

Flame Pharma - Medical Writer Job - North West, Cheshire

North West, Cheshire:  Excellent package

Flame Pharma is recruiting an experienced Medical Writer to work on European Multi-Country Trials (part of Global Trials) with responsibility for the conduct and management of medical writing needs across all its activities, ensuring the documentation meets required standards and contains appropriate information.  Our client is part of one of the largest worldwide chemical companies, and is a newly established pharmaceutical company specialising in the development of innovative treatments in the field of renal and gastro-intestinal therapies.

The Role:

The Medical Writer prepares documents such as clinical study reports, Investigator Brochures, Annual Updates and PSURs in line with regulation requirements and internal document standards.  The successful candidate will be involved in the preparation of more complex documents (e.g., CTD summaries, regulation responses, SPC and post marketing documentation) with direction from other members of the team.  The Medical Writer contributes to development work in relation to document standards, template development and other aspects of document management, plus overseeing the activities and performance of external vendors.

The Person:

A B.Sc. or higher degree in life sciences is required.  Proven medical writing experience with highly developed and proven medical writing skills is essential.  Candidates will have demonstrated success in the preparation of regulation documents, particularly at the individual study report level, and will have excellent working knowledge of appropriate ICH GCP guidance and application.  With experience of working with/within CROs, they will have well-developed computer skills including proficiency in Word, Powerpoint and Excel.  The ability & willingness to travel [UK and abroad] and a valid driving license is also required.

Key Words:

Medical Writer, Medical Writing, Drug Safety, PV, Pharmacovigilance, Drug Safety, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research, Cheshire, North West

For more information and to apply for this position, please contact Flame Health today on 0800 085 0858