2018 Experiential Internship - Medical Writing & Clinical Disclosure

Employer
AbbVie
Location
Lake County, Illinois, USA
Posted
Mar 23, 2018
Ref
1800523
Required Education
Bachelors Degree
Position Type
Full time
The AbbVie Experiential Internship Program


As an AbbVie Experiential Intern, you'll participate in a paid, ten to twelve-week summer program that is focused on providing students with robust projects throughout the summer. As an intern, you will be located at our corporate headquarters in north suburban Chicago, with housing and shuttle services for eligible students.

Department Overview - Medical Writing & Clinical Disclosure

The Medical Writing area within Medical Writing & Clinical Trial Disclosure leads the planning, writing, reviewing, and approving of global clinical regulatory documents, such as clinical study reports, investigator's brochures, and periodic safety reports. The Medical Writers and Medical Writing Managers provide expertise in scientific and regulatory writing, software for writing, presenting, publishing, distributing, and storing documents and clinical trial information, quality control, document formatting, and management of the content, archiving documents, and project planning and management in accordance with clinical and regulatory timelines. The Medical Writers are organized by Therapeutic Areas with an Associate or Assistant Director to lead each area..

Assignment Details

Responsible for providing regulatory document support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Publishing) to ensure accurate and timely completion/delivery of information and review of regulatory submissions.


  • Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated regulatory documents (US and exUS).
  • Develops a strong knowledge of US and international regulations, requirements and guidance associated with document preparation and submissions.
  • Serves as the Medical Writing representative on project teams. Communicates deliverables needed, writing process, and timelines to team members. Ensures all electronic document deliverables are processed and compiled in alignment with timelines.
  • Understands sources of information. Seeks out information to ensure complete documentation of all inputs. Converts relevant data and information into a form that meets regulatory document requirements. Interprets and explains data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, and tables.Verifies that results are consistent with protocols. Explains data in manner consistent with the target audience and regulatory requirements. Challenges conclusions when necessary.
  • Confirms completeness of information to be presented. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following established divisional guidelines, templates, and SOPs.
  • Arranges and conducts review meetings with the team.
Qualifications

Basic:

Completed at least one year of college education before beginning internship

Must be enrolled in school the semester following your internship

Under Graduate or Graduate Level student

Minimum Cumulative GPA: 3.0/4.0

Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated).

Majoring in a life science (biology, biochemistry) or English/communications

Relevant scientific experience

Equal Opportunity Employer Minorities/Women/Veterans/Disabled