Reg Affairs Assistant

Work Schedule

Environmental Conditions

Job Description

ADDITIONAL REQUIRED SKILLSETS:

Advanced Level Word Formatting Skills (Clinical and NonClinical Regulatory Documents) and Veeva experience (document upload).

Summarized Purpose:

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

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 departmentlevel training and job aids and regulatory metrics and business development documentation.
• Assists in the management on 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 semiroutine 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.

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

Management Role:

No management responsibility

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 46 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 1520 lbs.

Ability to access and use a variety of computer software developed both inhouse and offtheshelf.

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 guidance or reliance on oral or written instructions from management. May require periods of intense concentration.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multitask.

Regular and consistent attendance.

*This document is intended to describe the general nature and level of work being performed by this job. This document is not intended to be construed as an exhaustive list of all responsibilities duties and skills required. Individual responsibilities will be defined by your leadership team and will vary based on business needs.