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Document Specialist

Document Specialist

ID 
2018-1158
Category 
Regulatory Affairs
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

 

The Document Specialist focuses primarily on MS Office formatting of submission documents. This position will assist the Regulatory, Research and Clinical groups in preparing, formatting, reformatting submission documents, and ensuring adherence and consistency with existing corporate templates and styles. In addition, this position will assist with creating templates, and as time permits, assist in formatting non-submission documents (i.e., posters, journal article submissions, clinical site templates, etc.)

 

Responsibilities and Job Duties

 

  • Format, convert, and/or apply current templates and styles for all submission documents.
  • Train document authors/subject matter experts (SME) on basic word formatting.
  • Create, update, manage, train, and enforce submission document style manual.
  • Generate user guides/training manuals as needed.
  • Producing comparison documents for revisions using document comparison software as needed.
  • Ensure document metadata conforms to naming conventions and standards in Electronic Document Management System (EDMS).
  • Assist functional areas in creating and formatting submission document templates.
  • Assist document authors/SMEs with graphics/figures/tables creation and formatting.
  • Assist document authors/SMEs with literature reference citations in MS Word.
  • Assist with formatting of non-submission documents (posters, journal articles, conference materials, presentations, etc.) as time permits.
  • Assist Regulatory with publishing tasks as needed.

Qualifications

  

Education, Certifications & Experience

 

  • High School Diploma or equivalent
  • One year of document formatting/word processing experience
  • EndNote/Reference Manager Experience
  • Must be comfortable formatting specialized, technical and/or scientific documents

Knowledge, Skills and Abilities

 

  • Individual must possess the ability to influence without direct authority.
  • Ability to train and impart technical skills to large groups of people.
  • Must possess a high level of accuracy and attention to detail.
  • Results driven with demonstrated successful outcomes.
  • Ability to work as a team or independently.
  • Must possess ability to handle multiple priorities in a fast-paced, timeline-driven environment.
  • Must possess excellent written and verbal communications skills.
  • Must demonstrate advanced proficiency in the use of Microsoft software (word processing, email, spreadsheet, database, and Internet).
  • Ability to quickly learn technical software as it pertains to document processing, graphics and/or document control.
  • Must also be able to facilitate occasional projects not possible during normal business hours due to project timelines (e.g. ability to work weekends/nights to meet deadlines).

 

Supervisory Responsibilities:

 

No

 

Preferred Qualifications

 

  • BA/BS (Science degrees preferred)
  • Experience with an Electronic Document Management System (i.e. Veeva, FDRD, OpenText)
  • Experience with scientific graphs/figures software (i.e. GraphPad Prism), graphics applications (i.e. Photoshop), and Adobe Acrobat
  • MS Office Specialist Expert/Master Certification
  • Experience working in a biotech or pharmaceutical company

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.