Senior Medical Writer

Associate Principal Regulatory Writer

Contract - 6/12 months

Location - Fully remote (EU)

Salary - €70-90/hour (Outside IR35 UK)

Regulatory Writers prepare high quality documentation for regulatory submissions in order to help streamline the regulatory approval process for our clients. The Associate Principal Regulatory Writer (APRW) is a major contributor to document authorship for a variety of clinical documents across different therapeutic areas. The APRW will be the project lead on smaller projects, interfacing directly with the client, but also support larger, more complex engagements as a member of a larger delivery

team.

Responsibilities

• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents
• Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents)
• Author documents per client specifications, templates, style guides, and other guidance documents
• Author documents per regulatory authority guidelines and requirements.
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work
• Manage budget for a low complexity project, including all contributors (writers, editors)
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus
• Maintain collaborative, proactive, and effective communication with both client and internal teams
• Lead project-related meetings and teleconferences
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements

Qualifications

• Bachelor's degree; MSc or PhD preferred
• 8+ years of regulatory writing experience or equivalent experience with clinical sections of the CTD such as:

2.5 Clinical Overview

2.7 Clinical Summaries

Clinical Study Reports

Clinical Study Protocols

Briefing Documents

• Understand regulatory authority guidelines and requirements to be able to lead an internal project team and anticipate the effects that writing practice conventions can have on the final product when seeking health authority approval/acceptance
• Experience in the development of submission-level documents (does not require functioning as a document lead)

To find out more contact me via (see below)

Job Title: Senior Medical Writer

Location: London, UK

Job Type: Contract

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