Specialist, Regulatory Affairs

Location
Gaithersburg, MD
Posted
Jul 01, 2022
Ref
904320600
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

JOB SUMMARY 
The Regulatory Operations Formatting Specialist will be responsible for formatting MS Word and PDF documents to Emergent submission standards, and for importing and archiving documents into the EDMS system.

 

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

•    Format MS Word documents that have been provided by Regulatory Affairs according to the Emergent Style and Formatting guide standards. 
•    Format PDF files to ensure that they meet company-defined standards for submission, such as PDF version, bookmarks, links, OCR, etc. 
•    Import files into the EDMS System following current Emergent best practices. 
•    Create and modify document templates
•    Train new authors on formatting best practices, provide ad hoc support to resolve technical issues  
•    Manage multiple requests, meeting all timelines, and ensuring all updates are captured

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions. 

 

MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • Associate Degree in Administration, Science or Legal field preferred. 
  • Extensive knowledge of MS Word and other MS Office applications and Adobe Acrobat required.
  • Previous experience formatting documents with the use of paragraph styles preferred. 
  • Knowledge of ISI Toolbox and Veeva Vault or similar systems is also an asset. 
  • Detail oriented
  • Strong proficiency in computer applications
     

 

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment,  subject to legally required exemptions.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.