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Medical Writer Principal

Job Title: Medical Writer Principal
Contract Type: Permanent
Location: Paris, Île-de-France
Industry:
Salary: €65000 - €80000 per annum + relevant to experience, benefits package
Start Date: ASAP
Reference: 72837-PHARM-VLB_1541524296
Contact Name: Vladyslav Babych
Contact Email: Vladyslav.Babych@volt.eu.com
Job Published: November 06, 2018 17:11

Job Description

Duties and responsibilities:

Preparing and finalising scientific and clinical documents at the highest quality in terms of scientific content, inline with established timelines and processes
Managing projects and deciding on strategies within processing/timeline constraints and appropriate deviations from normal practice to meet unusual challenges.
You will provide mentorship to junior colleagues, overseeing the work of third parties medical writers, external contractors, and document specialists supporting a project.
Collaborating while working in a team and taking a dedicated role on multiple assigned projects with respect to timing, scheduling, and tracking.
Contributing scientifically and strategically and you may be leading submission-level, strategic activities for the writing team.
You will negotiating with and influencing others with regard to scientific content / processes.
This is an office based role, so you will be able to work from HQ location in central Paris
All processes and writing will be handled in English, however French speaking skills will be advantageous.

Qualifications:

Minimum Requirements:

Masters Degree in life science ; PHD or Medical Degree preferred
Experience in medical writing at least 5 years?
Strong scientific, medical writing skills including interpreting and organising scientific data.
Experience writing clinical regulatory submission / safety documents, such as Clinical Study Reports, Investigator's Brochures, Clinical Study Protocols, CTD Summary Documents.
Experience in project managing and working on cross-functional teams
In-depth knowledge of writing guidelines, such as ICH, FDA, AMA