Job Title: Documentation Specialist CMC

Job Description

We are seeking an experienced Documentation Specialist with expertise in CMC and injectables. The ideal candidate will verify regulated documents via workflows within electronic document management systems, ensuring adherence to submission timelines, complex publishing, and archiving. This role requires maintaining a thorough understanding of FDA regulations and processes governing the content and maintenance of controlled documents.

Responsibilities

• Verify regulated documents via workflows within electronic document management systems.
• Adhere to submission timelines, complex publishing, and archiving of regulated documents.
• Maintain working knowledge of regulations and processes required by the FDA.
• Create, assemble, and publish both major and routine global paper and electronic submissions, including NDAs, Annual Reports, Periodic Safety Reports, Supplements, Amendments, etc.
• Represent Regulatory Operations on project teams, driving timelines and deliverables related to submission documents.
• Review technical documents for accuracy and determine acceptability for use in new ANDAs, NDAs, Amendments, Supplements, Annual Reports, and other required FDA filings.
• Work on projects and solve problems by analyzing situations or data, requiring evaluation and sound interpretation of regulatory requirements and guidelines.

Essential Skills

• Experience within CMC and injectables.
• Proficiency in documentation control, regulatory compliance, and electronic document management systems (EDMS).
• Minimum of a Bachelor’s Degree in a life science.
• Minimum of 3 years in the pharmaceutical industry with 1-2 of those years in regulatory.

Additional Skills & Qualifications

• Experience with document verification.
• Strong understanding of FDA regulations.
• Ability to work effectively on project teams.
• Excellent problem-solving skills.

Work Environment

This position operates in a hybrid office setting. The work schedule includes onsite work from Tuesday to Thursday and remote work on Monday and Friday. The typical working hours are from 8am to 5pm.

Pay and Benefits

The pay range for this position is $90000.00 - $115000.00/yr.

• Excellent verbal and written communication skills.
• Demonstrates knowledge and understanding of FDA guidelines
• Performs duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
• Strong critical and logical thinker with ability to analyze problems and recommend solutions.
• With direction, effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
• Exercises sound judgement.
• Effectively prioritizes competing tasks in a fast-paced and dynamic environment.
• Highly motivated, results driven with unyielding predisposition to detail, accuracy and clarity.

Workplace Type

This is a hybrid position in Morristown,NJ.

Application Deadline

This position is anticipated to close on Mar 19, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $90,000 - $115,000