*Consultant, Head of Medical Writing - UK Remote - Part-Time (50% - 60%) - 9 month contract*
Are you an experienced Head of Medical Writing interested in joining our biotech client that is leading the way in developing innovative CAR-T cell therapies for cancer treatment?
We're hiring for a fast growing clinical-stage bio-pharmaceutical company at an interesting stage of development and an exciting opportunity has arisen for a highly experienced Consultant, Senior/Executive Director to join the Regulatory Affairs team on a temporary basis to oversee the Medical Writing team to support global expansion of their cell and gene therapy products.
Key Responsibilities
* Overall accountability for the Medical Writing function comprised permanent team members, consultants, and vendor partners, including cross-portfolio document development strategy (development and life cycle management), resourcing, budget, team development, and the 2025 goals.
* Proactively lead and oversee the writing team in the development of high quality, complex clinical documents for submission to regulatory authorities across the Company portfolio including but not limited to; briefing documents, complex CSRs, CTD module 2 documents, responses to questions/information requests, PIPs/iPSPs, protocols (original and amendments).
* Ensure all deliverables are developed and finalised in a timely manner with high quality in collaboration with the respective regulatory lead(s) and cross-functional partners, according to Company processes, external guidelines, global regulatory strategy, portfolio strategy, commercial strategy, and Product Labelling.
Experience
* 15+ years in Medical Writing, either pharma/biotech, or CRO/consulting.
* 7+ years in leading a medical writing team including contractors or matrix management (project and people management of overall resources).
* Demonstrated success with vendor management and relations.
* Experienced with team resourcing, balancing and adapting the utilisation of internal team members, consultants, and vendor partners. Ability to proactively and strategically forecast workload for the medical writing team to support resourcing and budget management.
Key Skills
* Excellent interpersonal, active listening, communication (written and verbal), presentation, and influencing skills to support ability to establish and maintain professional and productive working relationships across management, functional areas, and geographical locations.
* Effective collaborator who understands the role of cross-function team members with the ability to foster strong working relationships as well as build consensus within multidisciplinary teams through influencing and negotiating.
* Excellent ability to independently analyse, interpret, and present scientific and clinical trial data and understand statistical analyses, along with proactive information gathering and monitoring.
* Proven ability to prioritise and lead multiple demands and projects, strong organisational, problem solving and strategic skills.
If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lewis.ray@skillsalliance.com