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.
ResponsibilitiesVerify 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 SkillsExperience 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 & QualificationsExperience 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.
•\tExcellent verbal and written communication skills.
•\tDemonstrates knowledge and understanding of FDA guidelines
•\tPerforms duties with the highest ethical standards, delivering only high-quality, compliant submissions to FDA.
•\tStrong critical and logical thinker with ability to analyze problems and recommend solutions.
•\tWith direction, effectively communicates regulatory requirements and strategies as they affect regulatory submissions to internal and external partners.
•\tExercises sound judgement.
•\tEffectively prioritizes competing tasks in a fast-paced and dynamic environment.
•\tHighly 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 Feb 28, 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 & InclusionAt 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 peopleThe 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.