Oncology Medical Writer

Highly Competitive
  1. Permanent
  2. Medical Writing
  3. United States
Somerville, Massachusetts
Posting date: 04 Jul 2019
MC.SH.24182_1562247593

An internationally leading pharmaceutical company is seeking to recruit an Oncology Medical Writer to their office in Massachusetts. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.

Job Responsibilities:

  • Leads a single team which guides medical writing activities within a designated therapeutic area for key response documents and regulatory submissions.
  • Leads the writing strategy providing expertise including organization, content, timelines, and resource requirements.
  • Provides more complex advanced input for study designs, analysis plans, sections of INDs and marketing applications
  • Coordinates and provides oversight for the activities of medical writing vendor(s) (, and ensures resolution of issues.
  • Within designated therapeutic or compound function, manages deliverables and preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within therapeutic areas and adherence to regulatory requirements and company requirements and processes across development programs.
  • As required, serves as lead writer for strategic regulatory documents and key components of regulatory submissions.
  • Provides leadership on functional teams that address requirements or issues related to document preparation and production.
  • The Principal Medical Writer Program Lead is seen as an expert in medical writing and performs work independently with minimal supervision.

Skills and Requirements:

  • Bachelor's degree in science, health profession, or journalism required.
  • 5+ years of experience writing for pharma or biotechnology required.
  • 3+ years of electronic documents and submissions required.
  • Experience as lead writer for key documents included in major US and/or international regulatory submissions required.
  • Experience managing writing activities for a major US or international regulatory submission (project or people management) preferred.
  • 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.
  • Understanding of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 Sherron Howard at +1 267 435 8600 or upload your CV 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.

#LI-SH1

#MedicalAffairs

close