Principal Medical Writer

Key People


Job ID :

13676


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

Western Europe,--Lausanne,Lausanne,


Key Skills :

medical writing, writing, medical writer, lausanne, switzerland


Salary :

€150000 - €160000 per annum


Date Posted :

29 Nov, 2018



Company Name :

Key People


Location1 :

Lausanne




Job Category :

Medical Writing Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has become available for a Principle Medical Writer to join an exciting Biopharma, based in Lausanne.

Within this role you will be involved with the development of study-related documents, communication with health authorities, publications and presentations. You will also ensure compliance with international guidelines and internal quality standards and is accountable for the process of authoring, as well as write concise documents.

Main responsibilities:
Writing:
*Author documents such as protocols/amendments, informed consent forms (ICFs), clinical study reports (CSRs), Investigator's Brochures (IBs), briefing books, response documents, Paediatric Investigation Plans (PIPs). Manage review cycles, reconciliation of comments, and finalisation/approval of these documents.
*Review work of other writers (contractors or internal functional area representatives) for accuracy, quality, focus, and adherence to format and stylistic requirements.
Leadership:
*Provide leadership in cross-functional communication / team meetings to optimize feedback and input towards focused and high quality documents.
*Challenge and resolve conflict during document development and finalisation
*Drive process improvement and/or cross-functional initiatives (e.g., SOP review, template development).
Strategy:
*Develop the strategy for document preparation and the document review processes. Collaborate closely with the teams in order to better understand the needs, the planning, and timelines. Facilitate document review meetings and discussions.

Your profile:
*Minimum university life science degree or equivalent is required. Master's degree in a scientific area is preferred.
*7 years medical writing experience and/or other relevant pharma industry experience combined with the knowledge of drug development and regulatory requirements, plus extensive knowledge of medical writing processes.
*Proven experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
*Experience in early phase clinical development in Oncology.
*In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
*Good command of English and solid writing/editorial skills (understandable, at a level appropriate to the audience and the project).
*Strong ability to prioritize and manage multiple demands and projects with respect to deadlines.
*Ability to communicate scientific or medical information in a clear and concise manner.
*Self-starter, flexible, able to adapt quickly in a fast-moving environment, work efficiently within the given time and resources.
*Ability to lead and influence.


For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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