Regulatory Relations Specialist jobs in Haverhill, MA

Summary: Responsible for shipping/receiving activities including packaging, shipping documentation and inventory control of clinical study devices.

Duties and Responsibilities include the following.

• Responsible for working with the study Sponsor and Foresight Regulatory Strategies, Inc. (FRSI) project team to properly control the investigational materials.
• Responsible for coordinating clinical shipments for clinical study materials.
• Interfaces regularly with internal teams to accomplish daily shipping plans.
• Assist in the assembly of kits, formatting, and printing labels, overlabeling in accordance with internal procedures.
• Identifies, addresses, resolves, and communicates all on-going investigational material issues in conjunction with other members of the project team.
• Participates in internal audits and responds to audit findings.
• Assists in the development and production of clinical study material documentation and procedures.
• Reads, understands, and follows applicable FRS procedures and instructions.
• Accountable for the timely and accurate dissemination of inventory information to all site monitors and other project team members.
• Assists in the development of specific tools and documents for assigned projects and updates as necessary throughout the course of study.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.

Language Ability:

Ability to read and comprehend simple instructions, short correspondence, and memos. Ability to write simple correspondence. Ability to effectively present information in one-on-one and small group situations.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.

Reasoning Ability:

Ability to apply common sense understanding to carry out detailed but written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.

Computer Skills:

To perform this job successfully, an individual should have a working knowledge of Microsoft Word, Excel and Outlook, along with various internet search engines.

Education/Experience:

Associates degree in a related field or 5 years of work experience in a similar job position. Pharmacy Technician training a plus.

Knowledge, Skills, and other Abilities:

Highly organized
Good written and oral communication skills
Problem solving skills
Priority management
Works as team player
Maintains confidential and proprietary information
Positively represents the company
Works well with internal and external clients

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is regularly required to use their hands. The employee is frequently required to stand, walk, sit, talk, and hear. The employee is occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl and taste or smell. The employee must occasionally lift and/or move up to 40 pounds. Specific vision abilities required by this job include distance vision, near vision and the ability to adjust focus or wear devices that assist in this function.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. While performing the duties of this job, the employee is exposed to a normal office environment. The noise level in the work environment is usually low to moderate.

Job Type: Full-time

Pay: $18.00 - $22.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Retirement plan

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person