Associate Director - Medical Writing

Location London
Discipline: Quality Assurance, Regulatory Affairs
Job type: Permanent
Salary: £Salary: £85,000 - £100,000 Per annum + Generous benefits package
Contact name: Katie Dunbar

Contact email: Katie.Dunbar@rbwconsulting.com
Contact phone: 01293584300
Job ref: 20173
Published: about 1 month ago
Expiry date: 19 June 2021

RBW are working on behalf of a client in Central London who are looking for an experienced Medical Writer to support global clinical and regulatory documents for existing portfolio and their growing pipeline.

The Medical Writer manages the overall operations of a team or major project and implements this through effective leadership. Providing guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements.

Key Responsibilities:

  • Provide leadership related to the activities of the Medical Writing department

  • Collaborate with key stakeholders to ensure understanding of program strategy and the nature of medical writing services

  • Identify new technologies and initiatives related to the preparation of clinical documents

  • Proactively anticipate risks, solve complex problems, and seek out and implement process improvements

  • Provide input to strategies and tactics for the Medical Writing department

  • Independently prepare clinical regulatory documents, including protocols, study reports, investigator’s brochures, and sections of regulatory submission

  • Participate in developing key messages for complex clinical regulatory documents

  • Provide medical writing input for study designs and statistical analysis plans

  • Thoroughly analyze and critically interpret data to determine the best approach to composing each document

  • Provide expert review of documents

  • Proactively identify process and template improvements

  • Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies

  • Train, mentor, and supervise staff in the Medical Writing department

Key Requirements:

  • PhD (or equivalent degree) and strong relevant work experience.

  • Superior written communication skills

  • Experience writing and editing clinical regulatory documents

  • Ability to analyze, interpret, and summarize moderately complex data

  • Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology

  • Ability to manage project teams and form productive working relationships

  • Excellent project management and organizational skills

  • Ability to prioritize and manage multiple complex projects

  • Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results

  • Initiative and creativity in solving routine problems and in identifying and contributing to improvements in cross-functional process

  • Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools

This role is based in London, with minimum of 3 days in the office, enabling partnership with other functions and people management responsibilities. A great benefits package is on offer, along with a phenomenal culture and exciting workload.

To find out more about this fantastic opportunity or to discuss other open positions which may be of interest please contact Katie Dunbar on +44 (0) 1293 584 300 and send your CV through to katie.dunbar@rbwconsulting.com or use the apply button on this page.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign.

Salary: £85,000 - £100,000 Per annum + Generous benefits package