Richmond Pharmacology is the UK's largest early Phase Contract Research Organisation (CRO) conducting pioneering early phase healthy and patient volunteer trials. Our experienced and world-renowned team, our central London location and our global reach contribute to making Richmond Pharmacology an exciting and dynamic place to work.
We have a great opportunity for a Head of Advanced Research Science/ Medical Writing to lead and manage our Advanced Research Science team and contribute to our innovative work while expanding their existing skills within the clinical pharmacology sector.
This is a permanent role working over a 40-hour week and will report to the Director of Study Management.
You must have the ability to lead and manage a high performing team to deliver quality documents to our global client base. You must be able to work in a fast-paced working environment, prioritise effectively, follow company and regulatory standards including SOPs, ICH-GCP and other guidelines and be able to adapt writing style to the appropriate audience.
* PhD or MD
* Strong record of first author academic publications (at least 5)
* A minimum of 5 years' experience of line management of a medical writing group within academia or industry
* Experience in writing clinical study documents including but not limited to:
* Clinical Study Protocols - designing complex and adaptive studies taking into account, safety considerations for first-time-in-man studies
* Regulatory and Ethics submission management - to meet timelines and all regulatory requirements.
* Clinical Study Report Writing - data analysis and interpretation and understanding of pharmacokinetic, pharmacodynamic and safety analyses (including modelling and simulation)
* Advanced level of knowledge of all relevant industry guidance and standards (e.g. FDA, EMA, ICH, PMDA)
* Evidence of implementation of new processes and information in relation to best practices and standards, as well as emerging pharmaceutical industry guidance, enabling our advanced research science processes to remain leading edge and competitive
* Strong communication skills, both written and verbal required to articulate concepts and ideas
* Driven, persuasive and able to influence and have an impact at all levels of the organisation
* Experience and ability to manage outsourced writing activities and collaborations with other CROs and service providers
* *Tasks & Responsibilities*
* Recruit, manage and develop entry level to senior team members to support early phase clinical trial projects as well as support R&D projects within Richmond Pharmacology
* Liaise closely with Principal Investigators, biostatisticians, internal clinical and operational teams, pharmaceutical sponsors, regulatory authorities and other stakeholders to progress research programs of new medicines
* Ensure effective and efficient scientific document writing processes are implemented and maintained in order to meet all regulatory requirements to gain approval for studies
* Drive collaboration and innovation within the Advanced Research Science team as well as cross-functionally by interacting with other departments and externally
* Provide essential quality control (QC) training to the Advanced Research Science team and optimisation of clinical documents concurrently across a number of studies
* Ensure all departmental documentation created internally as well as outsourced documents are available and ready for inspection and audit and address relevant inspection, audit and CAPA items
In return, we offer a competitive remuneration package, including life assurance (3 x salary), private single medical and dental insurance and a generous holiday allowance, starting at 25 days, excluding bank holidays, increasing by 1 day per annum, up to a maximum of 30 days.
Please follow the link to our BambooHR candidates system and register your interest. You will be asked to supply a current CV and basic contact details.