Clinical Documentation Specialist
3 days ago
Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies.
About the Role
We are seeking an experienced Senior Medical Writer to join our growing team. You will play a critical role in shaping our medical and scientific communications, ensuring clarity, accuracy and impact for diverse audiences. As a leader and mentor, you will contribute extensively to project development, execution and sponsor satisfaction.
Main Responsibilities
- Lead junior medical writers to deliver high quality, fit-for-purpose clinical documents that accurately reflect associated data and are in line with global/regional/local regulatory and ethical requirements.
- Write and review various clinical and regulatory documents such as, but not limited to, clinical study protocols (CSPs), clinical study reports (CSRs), informed consent forms (ICFs), summary documents, advertising material and regulatory responses.
- Complete the following regulatory submissions independently: MHRA - IRAS, FDA - IND and EMA - CTIS.
- Ensure all information is accurate, balanced, and compliant with regulatory requirements.
Requirements
- At least 5 years of relevant clinical/regulatory medical writing experience is required.
- Publication(s) in peer-reviewed journals.
- Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
- Excellent written and verbal communication skills with a demonstrated ability to write clearly, concisely and accurately for a variety of audiences.
- Strategic thinking with strong planning and organisational skills.
Salary & Benefits
The salary for this position is £60,000 per annum, plus benefits including private medical insurance, private dental insurance, pension scheme, 25 days annual leave plus bank holidays and many more.
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