Senior Manager, Medical Writing job in Hatfield, England

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Medical Writing

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical is excited to announce a vacancy for a Senior Manager in Medical Writing to join a team in Hatfield. This is an amazing opportunity to combine your creativity and experience to a new role.

Job Responsibilities

As a lead writer, writes protocols and amendments, CSRs, global investigator brochures (GIB) and annual regulatory reports for assigned projects/programs.
Leads the preparation of clinical documents for submissions, such as Module 2 summaries, briefing books, and response documents.
Independently liaises with other functional areas and groups in the preparation of assigned documents
Implements document quality controls, standards and best practices
As needed, collaborates and provides guidance to other medical writers (eg, contractors) on team projects

Skills and Requirements

Experience as a lead writer in preparing clinical study protocols, CSRs, Module 2 clinical summaries, investigator's brochures, briefing documents, as well as other regulatory and clinical documents
Experience as a lead writer for a drug, leading the medical writing activities across a program
Prior experience in the Oncology therapeutic area is desired.
Excellent medical writing skills
Meticulous attention to detail
Proficiency using an electronic document management system
Strong analytical ability to interpret clinical data
Familiar with applicable ICH guidelines and medical writing style guidelines.

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Oliver Jones on 02038541077 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

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