Senior Medical Writer

4 weeks ago

Marlow, United Kingdom Kyowa Kirin International Full time

Overview:
At Kyowa Kirin International (KKI), our purpose is to make people smile. This means more than drug discovery and development; it is about embedding care into everything we do to make a difference every day for those that need it most. We’re an inclusive pharmaceutical company that takes time to understand what really matters to our patients, their families, and their healthcare professionals, helping our people to take bold actions that deliver life-changing solutions sooner. Our culture is rooted in our values: Teamwork, Commitment to Life, Innovation, and Integrity. They help us to push boundaries to deliver extraordinary impact and make KKI a brilliant place to work

**Job Purpose**:
Senior level medical writer to serve as the primary writer on projects and documents This is a hands on, individual contributor, writing position.

The incumbent will be required to work flexibly across a number of clinical stage projects, providing high level clinical regulatory writing support to various functions and projects through writing, editing, and reviewing clinically focused regulatory documents. This includes but is not limited to: Investigator Brochures, Clinical Protocols, Clinical Study Reports, Safety Narratives, Lay Summaries, eCTD Module 2 clinical-focused documents, Module 5 integrated summaries, and Health Authority briefings and responses.

Reports to the Associate Director, Medical Writing Site Manager

**Responsibilities**:
Prepare, edit, and review clinical documents documents including but not limited to: Investigator Brochures, Clinical Protocols, Clinical Study Reports, Briefing Documents, eCTD Module 2 clinical-focused documents, Module 5 integrated summaries, and Health Authority briefings and responses:

- Ensure that these documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messages, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
- Take ownership of a given assignment providing high‑level clinical‑regulatory writing support and serving as coordinator for document workflows.
- Critically evaluate, review, and interpret clinical data and medical literature. Proactively consult with other team members and department representatives for information or guidance as necessary.
- Perform data review, analysis activities, and quality control checks relevant to document type. Identifiy and resolve errors and inconsistencies in clinical data with project team members.
- Lead and enforce compliance with document creation SOPs and documents governing content.
- Secure maintain common ways of working and standards across projects and sites, establishing the role of medical writer as a fully integrated, global function on international study teams.
- Participate/recommend preparation/revision of document templates, development of processes (preparation/revision of SOPs) or other documents guiding content.
- Participate significantly in meetings at the product/program level
- Serve as _ad hoc_ member of project publication planning team. Identifies resource needs, as needed, to Director of Medical Writing. Provides assistance to project team (or Medical Affairs) as needed with creation or coordination manuscripts, abstracts, and posters
- Work successfully with a low level of direct supervision.
- Establishes clear and regular communicatin plan with Director, Medical Writing.

Qualifications:

- This position requires a Bachelors or Master’s degree in a scientific/medical/clinical discipline with at least 8 years or regulatory medical writing experience for a pharmaceutical company or contract research organization, and an understanding of clinical regulatory documentation requirements.
- PhD (in a scientific, medical, or clinical discipline), PharmD, MD (or equivalent) with at least 5+ years of regulatory medical writing experience for a pharmaceutical company or contract research organization, and an understanding of clinical regulatory documentation requirements would be preferred.
- High-level writing and editing skills with strong understanding of clinical data and the ability to organize and present information.
- Thorough understanding of all phases of the drug development process and the interdependencies between drug development and other functional areas.
- Comprehensive knowledge and understanding of ICH-GCP and experience as lead-writer for key documents in major US and international regulatory submissions is highly desirable.
- Added knowledge and understanding of, Canadian and EU regulatory environments; previous experience with CTA and IND submissions preferred

**Technical Skills**:

- Excellent English, both written and spoken.

**Non-Technical Skills**:
Will be required to manage multiple competing priorities and to work across a variety of teams from conception to completion providing proficient collaboration, confli

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