Here is a great opportunity to combine your scientific knowledge and writing skills in an important role with one of the world’s leading healthcare companies.
You will be responsible for the project management and preparation of vital safety regulatory reports for innovative products and part of a global team driving the development of our clients rich pipeline of new products to make a difference to the health and wellbeing of people across the world.
One of the world’s leading research based pharmaceutical companies, our client is driven by the passion and innovative spirit of its people. As a team, they work together in a collaborative environment to create new solutions that enrich lives across the world. Key to achieving that mission is their growing pipeline of new products across several indications.
Using your talent for consistent and accurate scientific writing you will manage the preparation of Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs), ensuring that they are of the highest possible quality and in line with internal/external guidelines and requirements
As a key member of Safety Team you will gain a good understanding of any drug safety issues, working closely with the Safety Science Leader to ensure that these issues are effectively communicated in documents you prepare. You will also have the opportunity to work with colleagues from a range of other disciplines across the globe, including, clinical development, clinical operations, marketing and regulatory, in order to gather the safety and other content of your documents. In this role you will also have the opportunity to contribute to best practices & continuous improvement within Regulatory Documentation.
Liaising with contributors, analysing and interpreting data, creating production timelines and managing the review and publication process, you will apply your project management skills to ensure that documents are delivered on time and in accordance with best practice. As a Regulatory Documentation Scientist, you will also provide leadership for a writing team responsible for the preparation of a suite of safety documents, ensuring sufficient allocation of resources along including outsourcing where required
QUALIFICATIONS / EXPERIENCE REQUIRED:
A PhD, MSc or equivalent in a biomedical discipline or qualifications in pharmacy, nursing or another healthcare discipline is required. Previous experience of writing scientific or medical reports, ideally within a pharmaceutical company environment, would be a distinct advantage. A good knowledge of medical terminology, ability to interpret data from a variety of sources, an accurate, clear and scientific style of written English and a competence in the compilation of safety documents will be essential to meet the demands of this position. Alongside your competence with the written word, you must be a skilled communicator, comfortable working as part of a team and with wider partners.
Pharmacovigilance Scientist, Drug Safety Officer, Regulatory Documentation Scientist, Medical Writer, safety regulatory reports, Hertfordshire, Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs)
For a confidential discussion please telephone Christian Simon at AXESS Limited on 020 8560 2300. To apply, please click on “apply now” in order to submit your details.
Only candidates with EU work authorisation will be considered.
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