Medical Writer, Non-Clinical (Contract)

US-NJ-Jersey City
ID
2018-1083
# of Openings
1
Category
Clinical Development

Overview

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach – and one of Japan’s oldest and most respected companies.

 

Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We’re currently building a new commercial organization and expanding our other functions to support this strategy.

 

The Medical Writer will provide regulatory, nonclinical and clinical documents support to the clinical development programs.  The writer will ensure successful preparation of high quality, submission-ready documents and effective implementation of the convention-based medical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include writing non-clinical and clinical CTD modules, study reports, protocols, executive summaries and briefing books.  Assisting the clinical development or regulatory team leads with generation of key preclinical and clinical reports and summaries.

Responsibilities

  • Prepares non-clinical and clinical reports, summary documents, investigator’s brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation.
  • Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical and clinical studies.
  • Works collaboratively, contributing to cross-functional teams and projects.
  • Develops and drives detailed project timelines according to team-specified deadlines.
  • Assists in the development of formats and guidelines for clinical documentation.
  • May prepare scientific manuscripts, abstracts and posters.
  • May also support clinical research associates and medical doctors in clinical protocol development.
  • Proactively keeps abreast of professional information, trends and technology through conferences, networking and other information sources and brings forward innovative ideas for consideration.
  • Perform other duties as assigned.

Qualifications

  • BA/BS required; in a related scientific discipline.
  • Advanced scientific degree (MS, Pharm D, PhD) is preferred.
  • 2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA–required regulatory documentation (e.g., CTD module 2.5, 2.6 and 2.7, pharmacokinetic and toxicology summaries and investigator brochures).
  • Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical data and reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences.
  • Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs.
  • Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed.
  • Strong project management skills; ability to multitask while driving towards critical deadlines on all projects.
  • Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.
  • Excellent written/oral communication skills. Good interpersonal skills; able to establish rapport with all functional leaders, experts and colleagues.
  • Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions.
  • Willingness to travel, though travel is likely infrequent.
  • Ability to sit or stand for long periods of time
  • Manual dexterity required to operate office equipment, i.e. computers, phones, copy machine/printer
  • Ability to carry, handle and reach for objects
  • Ability to lift and pull up to 15 pounds

Options

Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed