Head of Advanced Research Science/Medical Writing in London

Job description

We're looking for a candidate to this position in an exciting company.

• 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
  

• 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

Extra information

Status

Closed

Education Level

Secondary School

Location

London

Working hours per week

0 -

Type of Contract

Full Time Jobs

Profession type

Customer Service

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English