Manager - Senior Medical Writer

Highly Competitive Salary
  1. Permanent
  2. Medical Writing
  3. United States
Bedminster, New Jersey
Posting date: 06 Jun 2019
MC.GW.23782_1559858396

ProClinical is currently seeking a Senior Manager of Medical Writing for a global specialty pharmaceutical company. Successful candidate will be responsible for facilitating, managing, and authoring clinical documents and collaborate with other departments such as Clinical Development, Development Operations, Biostatistics and Regulatory Affairs to set the strategy in the planning and preparation of documents within the assigned time frames.

Job Responsibilities

  • Communicate timelines, documents needed and process standards to the team.
  • Interpret and explain data from a variety of sources.
  • Comply with internal and external processes, SOPs, and appropriate guidelines.
  • Interact with a cross-functional team through the document development process related to authoring and reviewing of clinical documents.
  • Manage medical writers within specific therapeutic programs to mentor and cross-train.
  • Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced.

Skills and Requirements

  • BA/BS within a scientific field. PharmD, PhD, MD preferred.
  • 6+ years of medical writing experience within the pharma/biotech/device/CRO industry, preferably with demonstrated leadership progression and management experience.
  • Solid experience in strategic medical writing including interpretation of clinical data.
  • Experience-based understanding of applicable regulations and 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 call George Watson at (+1) 929-223-4385 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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