SPECTRAFORCE
Position Title:
CMC Regulatory Technical Writer II
Work Location:
Morristown, NJ (HYBRID)
Assignment Duration:
11+ Months
Starting Pay:
$54.00/hr
Notes
Fully Remote
Candidate local to Morristown: Hybrid required
Paid parking required nearby
Public transportation available nearby
Description The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in lifecycle management (LCM) programs. They collaborate directly with global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU and rest of world (ROW) dossiers (e.g. NDA, MAA, IND, and IMPD).
Key Responsibilities The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines. This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs.
The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:
following regulatory guidelines, source documentation, and templates
collaborating and coordinating with key stakeholders across the GBU’s, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
avoiding unsolicited regulatory burden
supporting the development of regulatory risk mitigation strategies
maintaining up‑to‑date knowledge of ways of working, SOPs, and CMC regulations and guidelines
supporting the planning and preparation of timelines
Skills and Experience Must Have:
3‑5 years of experience
Authoring experience (Modules 2 and 3)
Ability to work independently
CMC regulations/scientific background
MS Office proficiency
Nice to Have:
Veeva or Documentum experience
Medical device experience
Education BS/BA, MS, or PhD in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
Benefits For information on benefits, equal opportunity employment, and location‑specific applicant notices, click here.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.
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CMC Regulatory Technical Writer II
Work Location:
Morristown, NJ (HYBRID)
Assignment Duration:
11+ Months
Starting Pay:
$54.00/hr
Notes
Fully Remote
Candidate local to Morristown: Hybrid required
Paid parking required nearby
Public transportation available nearby
Description The CMC Regulatory Technical Writer II is a designate of the CMC Dossier Development team and participates in lifecycle management (LCM) programs. They collaborate directly with global business units (GBU) - Specialty Care, Vaccines, General Medicines, and Consumer Healthcare - by contributing to US, EU and rest of world (ROW) dossiers (e.g. NDA, MAA, IND, and IMPD).
Key Responsibilities The technical writer develops and authors chemistry, manufacturing, and controls (CMC) common technical documents (CTD) for development and post‑approval regulatory dossiers within pre‑established timelines. This includes responses to health authority inquiries, regulatory dossier amendments, supplements, variations, and annual reports. Additionally, the technical writer authors and evaluates change controls for global regulatory impact, and is sometimes called upon to author technical reports, position papers, white papers, or SOPs.
The technical writer assures regulatory dossier compliance and independently authors high quality CMC content by:
following regulatory guidelines, source documentation, and templates
collaborating and coordinating with key stakeholders across the GBU’s, contract manufacturing organizations (CMO) and functional areas such as Quality, Manufacturing, and Global Regulatory Affairs (GRA)
avoiding unsolicited regulatory burden
supporting the development of regulatory risk mitigation strategies
maintaining up‑to‑date knowledge of ways of working, SOPs, and CMC regulations and guidelines
supporting the planning and preparation of timelines
Skills and Experience Must Have:
3‑5 years of experience
Authoring experience (Modules 2 and 3)
Ability to work independently
CMC regulations/scientific background
MS Office proficiency
Nice to Have:
Veeva or Documentum experience
Medical device experience
Education BS/BA, MS, or PhD in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
Benefits For information on benefits, equal opportunity employment, and location‑specific applicant notices, click here.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.
#J-18808-Ljbffr