Medical Writer

United Kingdom · Medical Affairs

Description

Medical Writer

Reporting to; Head of Medical Writing and Publications

Location; Harefield

Tenure; Full-time, permanent

MAIN PURPOSE:

Reporting to the Head of Medical Writing and Publications, the Medical Writer will be responsible for the production of a range of medical and regulatory documents to support the company’s portfolio of drugs in development. The Medical Writer will also act as a key liaison to external medical writer(s) to ensure production of high quality and appropriate scientific documents. Furthermore, they will be responsible for the maintenance of medical and regulatory documents for use in submissions.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Key responsibilities of the Medical Writer will include the production of the following documents, which will be managed either directly or through contract serviced providers:

Clinical Study Protocols

High level documents for regulatory submissions

Integrated Clinical Study Reports

Integrated reports of combined data sets

Investigator Brochures

Paediatric Investigation Plans

Publications

In addition the Medical Writer will be expected to oversee the availability of medical and regulatory documents for submissions with a focus on version control and document quality. Furthermore, the Medical Writer need to remain current with relevant legislation and guidance, and ensure that the Medical Affairs group is kept informed of any impact on the operational activities.

MAIN TASKS

To ensure that assigned medical writing projects are managed and completed in an effective, reliable, timely, and competent manner:

To effectively manage external service providers to ensure their optimal performance and high quality of all deliverables (supporting the responsible Clinical Trial/Project Manager)

To provide medical writing capacities in-house for relevant medical and regulatory documents

To work with Regulatory Affairs and Technical Development to ensure that all documents met the required standard and content

To provide input into Medial Writing and Publications processes and procedures

To work in close collaboration with all colleagues within the therapy areas, particularly the Therapy Area Directors and the Clinical Trial/Project/Programme Manger(s), as well as colleagues within Medical and Regulatory Affairs.

PROJECTS

Will be identified, prioritised and assigned by the Head of Medical Writing and Publications.

ACCOUNTABILITY

Accountable to the Head of Medical Writing and Publications for all aspects of the management and conduct of assigned tasks for Medical Writing and Publications projects.

RELATIONSHIPS:

This position reports to the Head of Medical Writing and Publications within Medical Affairs of Norgine. Close collaboration with other Norgine personnel throughout the organisation are essential and include as internal interfaces, for example, the Therapy Area Physicians, Therapy Area Directors and Clinical Trial/Project Managers. External relations are mainly linked to the selected Service Providers for an assigned task(s). The ability to work successfully in a matrix organisation is required.

KEY SUCCESS FACTORS

SKILLS & KNOWLEDGE

Norgine is a leading European specialist pharmaceutical company with a direct commercial presence in all major European markets. In 2017, Norgine’s total net sales were EUR 345 million, up 17 per cent.

Norgine employs over 1,000 people across its commercial, development and manufacturing operations and manages all aspects of product development, production, marketing, sale and supply.

Norgine specialises in gastroenterology, hepatology, cancer and supportive care.

Norgine is headquartered in the Netherlands. Norgine owns a R&D site in Hengoed, Wales and two manufacturing sites in Hengoed, Wales and Dreux, France.

For more information, please visit www.norgine.com

In 2012, Norgine established a complementary business Norgine Ventures, supporting innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

Please note that we do try to provide specific feedback to all applications, however sometimes due to the volume of applications received we can respond only to those candidates who best match the position requirements.
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