CMC Writer Project Manager at TekWissen LLC

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 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: Bachelors 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. Key Skills Photography,Proofreading,Fact check,Interviewing,AP Style,Journalism,SEO,Copywriting,Creative Writing,Wordpress,Blogging,Writing Skills Employment Type : Full Time Experience: years Vacancy: 1