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Medical Writer / Senior Medical Writer

Takeda Pharmaceuticals

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Location: Chicago, IL Posted Date: 5/6/2013 Position Type: Full time Job Code: 1300273 Required Education: Bachelors Degree

Description

Please note that the requirements specified in this posting are the basic qualifications required for the Medical Writer position; however, job title will be dependent on the candidate's level of experience in those requirements.

OBJECTIVE:

Executes medical writing activities for projects in accordance with applicable US and international regulatory regulations and Takeda requirements under the supervision of the Associate Director, Medical Writing.  Assumes primary responsibility for preparation of regulatory response documents and documents supporting major regulatory submissions, under the direction of the manager. Participates on relevant project teams and task forces, and provides guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, Takeda requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.

ACCOUNTABILITIES:

* Prepares documents for submission to FDA or other regulatory agencies, in accordance with team input, with oversight from the manager.
* As required, provides review and substantive editing of contributions from external contract writers.
* Serves on teams and task forces, and provides guidance for document preparation and production to team members from other functional areas (nonclinical, safety, CMC, clinical).
* Participates on functional teams that address requirements or issues related to document preparation and production.

Requirements

Please note that the requirements specified in this posting are the basic qualifications required for the Medical Writer position; however, job title will be dependent on the candidate's level of experience in those requirements.

EDUCATION, EXPERIENCE AND SKILLS:
Education and Experience:
Required:

* Bachelor's degree in science, health profession, or journalism
* Minimum 2 years experience writing for pharma or biotechnology or equivalent experience (eg, academia or scientific publications)
* Advanced degree in science, health profession, or journalism preferred
Knowledge and Skills:

* Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
* Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
* Ability to understand Takeda guidelines and requirements related to the preparation and production of regulatory documents and submissions.
* Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers.
* Ability to identify issues and generate solutions or request appropriate intervention by management.

TRAVEL REQUIREMENTS:

* Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required.
* Requires less than 10% travel.

We are driven to improve people's lives.

www.takedajobs.com

We are an equal opportunity employer.

No Phone Calls or Recruiters Please.

*LI-AN1
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