Job Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide.
Job Title: CMC Writer / Project Manager
Location: Paramus, NJ, 07652
Job Type: Temporary Assignment
Duration: 5+ Months
Work Type: Onsite
Shift: 9.00AM-5.00PM
Shift: 9.00AM-5.00PM
Job Description:
- Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.
- This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.
Key Responsibilities
- Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
- Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
- Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.
- Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
- Collaborate with cross-functional teams to gather accurate technical information.
- Identify and communicate potential regulatory risks; propose mitigation strategies.
- Support process improvement initiatives for CMC submission workflows.
Qualifications
Education:
- Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
Experience:
- Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
- Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.
- Familiarity with global regulatory frameworks and eCTD submissions.
- Excellent technical writing, communication, and organizational skills.
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
- Veeva Vault, Smartsheet are plus
Preferred Skills
- Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.
- Ability to interpret and apply regulatory guidelines effectively.
- Strong project management and stakeholder communication skills.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Paramus, NJ |
| Industry | Computer/IT Services |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.Skills
- Accounts Receivableunmatched
- Biotech and Pharmaceuticalunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Delivery Managementunmatched
- Diversityunmatched
- Documentationunmatched
- Drug Developmentunmatched
- FDA (Food and Drug Administration)unmatched
- ICH Regulationsunmatched
- International Healthunmatched
- Interpret Regulationsunmatched
- Investigational New Drug (IND)unmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Analysisunmatched
- Manufacturing/Industrial Processesunmatched
- Marketing Authorization Application (MAA)unmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft Outlookunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Organizational Skillsunmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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