Overview

Reference Number: JO-2007-451527
Head of Advanced Research Science/Medical Writing
Rate: Negotiable
Job Type: Permanent
Location: City

Role: Head of Advanced Research Science/Medical Writing
Location: London Bridge
Salary: competitive + benefits
employment: full time, permanent

Regulatory Professionals are collaborating with a global, commercial-stage biopharmaceutical company dedicated to developing and commercializing novel therapeutics to treat patients suffering from serious and life-threatening rare diseases. You be responsible for leading and managing our clients Advanced Research Science team and contribute to their 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.

Other duties will include:

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 main-tained 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 opti-misation 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

Requirements:
Academic Qualifications
PhD in a life sciences subject
Strong record of first author academic publications (at least 5)

Personal Experience:
Right to work in the UK
A minimum of 5 years experience of line management of a medical writing group within aca-demia 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 require-ments.
Clinical Study Report Writing data analysis and interpretation and understanding of pharma-cokinetic, 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 re-search
science processes to remain leading edge and competitive

Management Experience:
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

If you would like to apply for this position, please contact Amani via amani.yousef@Regulatoryprofessionals.com. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*