Regulatory Affairs Assistant (Remote)

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.

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

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, 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 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.

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 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 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 multi-task.
• Regular and consistent attendance.

Percent Billable: 80% - 100%

Accessibility/Disability Access

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

EEO & Affirmative Action

Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards