Principal Medical Writer - Madrid, España - Sobi

Sobi

Empresa verificada

Madrid, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Company Description

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them.

Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

We are looking for an experienced Medical Writer. The role is a permanent position reporting to the Head of Medical Writing.

The Principal Medical Writer will provide expert leadership, strategic thinking and communication skills and expertise in the preparation of clinical regulatory documents throughout drug development, post-marketing and life-cycle management.

Lead a strategydriven approach to authoring of the clinical components of regulatory submissions, ensuring a clear, concise and complete scientific content aligned with the objective of the regulatory document
Assume primary responsibility for preparation of key clinical regulatory documents and documents supporting major regulatory submissions as well as responses to regulatory agencies/ health authorities
Provide leadership and project coordination to crossfunctional authoring teams, ensuring efficient delivery, high quality, and regulatory compliance of clinical regulatory documents
Liaise with senior project staff, prospectively develop a storyboard for the submission, and plan document development to provide optimal support for the proposed prescribing information
Assume a Product Medical Writer responsibility, providing strategic medical writing expertise and support to multiple projects in a clinical development program
Ensure high technical quality of the documents in compliance with inhouse technical requirements
Coach and develop less experienced Medical Writers
Oversee and coordinate all Medical Writers assisting on documents under your responsibility, including inhouse consultants and Medical Writers at CRO

Qualifications

Life Science Master ́s degree or PhD
A minimum of 810 years' experience in regulatory medical writing combined with scientific and regulatory knowledge, plus indepth knowledge of regulatory medical writing processes
Experience in leading complex global regulatory and clinical writing projects, such as complex CTDs, ODDs, PIPs, briefing documents and regulatory responses
Experience as lead author for major US and/or EMA regulatory submissions, including coordinating the work of other Medical Writers assisting on documents under your responsibility
Clear understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products
Advanced knowledge of global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements)

**Additional Information