Job Description

Position Overview

Provides administrative support to the department, including management and maintenance of regulatory documents, tools, and websites.

Employment Type

Full-time

Work Schedule

Standard (Mon-Fri)

Location Type

[Information Not Provided]

Salary

[Information Not Provided]

Environmental Conditions

Office

Additional Required Skillsets

• Advanced Level Word Formatting Skills (Clinical and Non-Clinical Regulatory Documents)
• Veeva experience (document upload)

Essential Functions and Other Job Information

Essential Functions:

• Provides administrative support to the department including travel arrangements, coordination of expenses, meeting planning and preparation of presentations.
• Manages the document archiving and retrieval process, including maintaining archive areas for:
  • Departmental processes/mapping
  • Department-level training and job aids
  • Regulatory metrics and business development documentation
• Assists in the management of SOPs/WPDs.
• Assists in revision and maintenance of department webpage, as needed.
• Assist with maintenance of utilization/resourcing tools.
• Assist with archiving of documents and submissions.

Job Complexity:

Works on assignments that are semi-routine in nature but recognizes the need for occasional deviation from accepted practice.

Job Knowledge:

Applies acquired job skills and company policies and procedures to complete assigned tasks.

Supervision Received:

Normally follows established procedures on routine work, requires instructions only on new assignments.

Business Relationships:

Contacts are typically with individuals within own department and occasionally with contacts outside own organization. Contacts involve obtaining or providing information or data requiring some explanation or interpretation.

Management Role:

No management responsibility

Qualifications

Education and Experience:

• High school / Secondary school diploma or equivalent and relevant formal academic / vocational qualification.
• Technical positions may require a certificate.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
• Prior experience in the pharmaceutical/CRO industry is preferred.
• In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.

Knowledge, Skills and Abilities:

• Good organizational and planning skills to effectively manage shifting priorities.
• Capable of working effectively on a team and/or independently with minimal supervision.
• Good electronic document production skills.
• Good proficiency in several computer applications including Microsoft Office software.
• Good attention to detail and quality of documentation.
• Good interpersonal skills with the ability to interact with customers.
• Solid verbal and written communication skills.
• Capable of multitasking and managing multiple projects.

Working Conditions and Environment:

• Work is performed in an office or clinical environment with exposure to electrical office equipment.
• Occasional drives to site locations.
• Potential occasional travel required.

Physical Requirements:

• Frequently stationary for 4-6 hours per day.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional mobility required.
• Occasional crouching, stooping, bending and twisting of upper body and neck.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
• May interact with others, relating and gathering sensitive information. Interaction includes diverse groups.
• Works with [Information Incomplete]