Regulatory Writer - remote
PRIMARY PURPOSE OF THE ROLE
To provide high-quality, concise, and accurate regulatory documentation that meets the expectations of both clients and regulatory authorities.
CORE RESPONSIBILITIES
* Author regulatory documents across various therapeutic areas, ensuring outputs are clear, factual, scientifically accurate, and free from over-interpretation.
* Adhere to established standard operating procedures and regulatory processes provided by clients.
* Demonstrate a foundational understanding of the expectations of regulatory authorities for submissions.
* Review client-supplied materials critically, including protocols, statistical analysis plans (SAPs), data listings, templates, and style guidelines.
* Assess documentation quality, data integrity, and project resource use—taking prompt action where issues are identified.
* Conduct accurate data checks of documents created by peers to ensure consistency and quality.
* Perform literature searches using publicly available or commercial databases to verify citations, locate references, and gather background context or regulatory precedent.
* Collaborate directly with clients to manage timelines and address emerging issues.
* Juggle multiple concurrent projects efficiently while meeting deadlines and maintaining quality standards.
* Proactively notify team members of risks or potential problems.
* Communicate clearly and professionally with internal team members and external contacts.
* Deliver work on time and within agreed-upon budgets.
* Follow internal and client-aligned procedures consistently.
* Contribute to additional duties as reasonably required to support project or business needs.
CORE DELIVERABLES
* Produce a wide range of documents, which may include (but are not limited to):
* Clinical study protocols
* Clinical study reports (CSRs)
* Executive summaries
* Common Technical Document (CTD) clinical summaries
* Investigator brochures (IBs)
* Clinical trial authorisation (CTA) documents
* Patient narratives
BENEFITS
* Unlimited Holiday Policy (including office closure between Christmas and New Years)
* Bonus scheme
* Healthcare
* Pension
* Flexible working hours
* Extensive training development