Reporting to; Head of Medical Writing and Publications
Tenure; Full-time, permanent
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
Paediatric Investigation Plans
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.
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.
Will be identified, prioritised and assigned by the Head of Medical Writing and Publications.
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.
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
- Good scientific writing skills in English
- Exemplary written and oral communication skills in English
- Ability to plan ahead
- Ability to demonstrate flexibility and motivation
- Ability to work effectively under pressure and to prioritise workload
- Ability to maintain a tolerant, patient, level-headed and calm approach at all times and particularly when under pressure
- Negotiation skills to effectively manage external service providers for medical writing/reporting activities
- Excellent interpersonal skills; ability to communicate effectively at all levels with third-party providers and within Norgine in a multicultural setting
- Ability to communicate in a clear, positive fashion to colleagues, staff, and management at all times while retaining appropriate levels of confidentiality
- Ability to work on own initiative and make decisions but with the confidence to ask for advice when necessary
- ‘Can-do’ attitude, pro-active approach and enthusiastic outlook to meet all challenges
- Willingness to work in a matrix environment and to value the importance of teamwork
- A good clinical knowledge with an understanding of medical terminology and the basics of physiology and pharmacology
- Demonstrate high standards of professionalism at all times
SKILLS & KNOWLEDGE
- Demonstrable medical writing experience in the pharmaceutical industry
- Proven experience of the management of external service providers for medical writing tasks
- A detailed understanding of regulatory requirements for submissions in the EU, US and ROW
- An understanding of the full clinical trial process, particularly related to all aspects of reporting
- Medical writing experience for all phases (I-IV) of clinical trials, is preferred
- Knowledge of ICH/GCP and EU Clinical Trial Directive
- Scientific ability to understand technical and medical requirements of the clinical study and/or clinical development plan
- Understanding of the drug development process
- Knowledge and understanding of SOPs
- Experience of working within agreed budgets
- Degree in Life Science
- A higher qualification is preferred but not essential
- Business management skills preferred but not essential
- Must be a holder of a valid driving license for driving in the UK
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.