SOKOL GxP Services
Technical Writer - CMC Regulatory Submissions (Hybrid, New Brunswick)
SOKOL GxP Services, New Brunswick, New Jersey, us, 08933
SOKOL GxP Services is hiring a Technical Writer – CMC Regulatory Submissions
to support our client’s team in
New Brunswick, NJ . This hybrid role will be part of the
Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO) . As a key contributor, you will be responsible for preparing
CMC documentation, including dossiers and supporting materials , that shape the regulatory strategy for the Cell Therapy clinical portfolio — spanning from
early-stage development through registrational filings . This role offers the opportunity to collaborate closely with subject matter experts across
Process Development, Analytical Development, Technical Operations, Quality, and Regulatory Sciences , ensuring high-quality, timely submissions that advance transformative therapies to patients. Key responsibilities include: Author and co-author CMC content
for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy. Plan and lead submission kick-offs , managing detailed timelines, deliverables, and cross-functional collaboration. Coordinate and track submissions , including responses to Health Authority questions, data verification, and final dossier preparation. Partner with subject matter experts (SMEs)
across CTDO to identify source documents, align on timelines, and deliver approved technical content. Ensure consistency, clarity, and accuracy
of messaging across all CMC documentation. Review and reconcile comments
with SMEs, manage revisions, and facilitate efficient comment resolution. Provide oversight for eCTD Modules 2.3 and 3 , ensuring compliance with formatting, structure, and regulatory requirements. Collaborate with external partners
as needed to review and finalize CTD content. Drive process improvements
and contribute to best practices in regulatory writing and document management. Mentor and train team members
on technical writing standards, systems, and submission processes. Requirements Bachelor’s degree in
Biology or a related discipline ; advanced degree preferred. Minimum
2 years of experience
in biotech or pharma, with a focus on
end-to-end product development . Strong knowledge of
regulatory requirements
and guidance for CMC documentation;
cell therapy CMC experience required . Familiarity with
eCTD structure
and
BLA submissions
strongly preferred. Exceptional
scientific writing and editing skills
with strong attention to detail. Proficiency in
Microsoft Office Suite
(Word, Excel, PowerPoint, SharePoint); experience with document preparation tools and compliance-ready standards. Excellent
planning, organizational, and communication skills , with the ability to manage multiple priorities in a fast-paced environment. Proven ability to work independently while thriving in
cross-functional team settings . Benefits Competitive hourly rate:
$34 – $44/hr (W-2 only, no C2C) Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (PTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company
to support our client’s team in
New Brunswick, NJ . This hybrid role will be part of the
Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO) . As a key contributor, you will be responsible for preparing
CMC documentation, including dossiers and supporting materials , that shape the regulatory strategy for the Cell Therapy clinical portfolio — spanning from
early-stage development through registrational filings . This role offers the opportunity to collaborate closely with subject matter experts across
Process Development, Analytical Development, Technical Operations, Quality, and Regulatory Sciences , ensuring high-quality, timely submissions that advance transformative therapies to patients. Key responsibilities include: Author and co-author CMC content
for CTD Quality sections, ensuring alignment with regulatory strategy and scientific accuracy. Plan and lead submission kick-offs , managing detailed timelines, deliverables, and cross-functional collaboration. Coordinate and track submissions , including responses to Health Authority questions, data verification, and final dossier preparation. Partner with subject matter experts (SMEs)
across CTDO to identify source documents, align on timelines, and deliver approved technical content. Ensure consistency, clarity, and accuracy
of messaging across all CMC documentation. Review and reconcile comments
with SMEs, manage revisions, and facilitate efficient comment resolution. Provide oversight for eCTD Modules 2.3 and 3 , ensuring compliance with formatting, structure, and regulatory requirements. Collaborate with external partners
as needed to review and finalize CTD content. Drive process improvements
and contribute to best practices in regulatory writing and document management. Mentor and train team members
on technical writing standards, systems, and submission processes. Requirements Bachelor’s degree in
Biology or a related discipline ; advanced degree preferred. Minimum
2 years of experience
in biotech or pharma, with a focus on
end-to-end product development . Strong knowledge of
regulatory requirements
and guidance for CMC documentation;
cell therapy CMC experience required . Familiarity with
eCTD structure
and
BLA submissions
strongly preferred. Exceptional
scientific writing and editing skills
with strong attention to detail. Proficiency in
Microsoft Office Suite
(Word, Excel, PowerPoint, SharePoint); experience with document preparation tools and compliance-ready standards. Excellent
planning, organizational, and communication skills , with the ability to manage multiple priorities in a fast-paced environment. Proven ability to work independently while thriving in
cross-functional team settings . Benefits Competitive hourly rate:
$34 – $44/hr (W-2 only, no C2C) Hybrid schedule (50% onsite Tu – Thu; full onsite during the first month) 12-month contract with possible extension Health benefits, holiday pay, and 401(k) program Paid time off (PTO) and professional development support Employee referral bonus program Opportunity to contribute to high-impact projects with a leading biopharma company