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Lead Medical Writer

Lead Medical Writer – Germany

Clintec is actively recruiting for a Lead Medical Writer to join our expanding global company in Germany. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.

Role Description:

Lead Medical Writer is responsible for writing, reviewing and editing medical writing documents including regulatory and medical communication deliverables under the guidance of medical writing managers and directors. In addition, the Lead Medical Writer shall co-ordinate medical writing activities between the internal team and client, ensuring projects are completed on or ahead of time and on budget, according to the applicable SOPs.

Responsibilities of the Lead Medical Writer:

Perform comprehensive literature reviews in support of international regulatory submissions
Author documents per client specifications, templates, style guides, and other guidance documents
Maintain collaborative, proactive, and effective communication with both client and internal teams
Participate in project-related meetings and teleconferences
Act as a client point of contact
Maintain collaborative, proactive, and effective communication with both client and internal teams
Participate in project-related meetings and teleconferences

Essential Criteria:

Master’s degree (preferably PhDs, MDs)
Ability to write at a level appropriate to the target audience
Demonstrates thorough research & understanding of the therapeutic area & scientific/market environment
Ability to use PowerPoint, Microsoft Word and Microsoft Excel
Relevant experience in developing CTD documents – 2.5, 2.7, 5.2 and 5.4 sections.
ISS and ISE sections
Fluency in written and spoken English
Eligible to live and work in Germany

Company Information:

Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.

Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective. We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.

Closing Date:
12/11/2018

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