CK Clinical is currently looking for a Regulatory Documentation Scientist to join a global pharmaceutical company based in Hertfordshire, UK.
Regulatory Documentation Scientist Job Description
As Regulatory Documentation Scientist, you will be responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions. Previous experienced in preparing Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) is desired.
Key responsibilities of this Regulatory Documentation Scientist role will include:
– Using your talent for consistent and accurate scientific writing you will manage the preparation of Development Safety Update Reports (DSURs) – Also responsible for preparing 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 – Work closely with the Safety Science Leader to ensure that 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, skills and experience:
As Regulatory Documentation Scientist, you will have the following qualifications, skills and experience: – PhD, MSc or equivalent in relevant scientific discipline, or healthcare professional – Post doctoral or previous pharmaceutical experience would be an advantage – Competence in the preparation of a variety of regulatory documents – Strong communication and organizational skills – Strong interpersonal skills – Excellent knowledge of regulatory documentation guidelines pertinent to subject area i.e. Clinical/Safety
How to apply:
Click here to apply online now. For more information, please contact Hendre Moolman at CK Clinical on +44 (0)1438 870 023 or email firstname.lastname@example.org. Please quote reference CL24229 in all correspondence.