Position: CMC Regulatory Technical Writer II Location:NJ candidates: hybrid schedule (2x week) Boston candidates: in-person training, fully remote after Duration: 12 months
Work Schedule
9 am-5 pm mon-fri
In-person or Remote: (East Coast with initial training onsite at Bridgewater, NJ, and few days for the first few months) HM Notes:
Open to local candidates only NJ candidates: hybrid schedule (2x week) Boston candidates, In-person training, fully remote after
Education: minimum qualification is a Bachelors in Biology, or Pharmacy
Must-Have Experience with: authoring Module 2 and 3 CTD sections (from scratch or updates), VEEVA, life-cycle tools, MS Suite especially Word & Excel
Preferred experience: Regulatory affairs, CMC • Work Experience: 5 years of industry experience
Duties The CMC Regulatory Technical Writer II authors high-quality Module 2 and 3 regulatory submissions for both development and post-approval dossiers, change controls and technical reports. He/she/They coordinates directly with key stakeholders within clients's industrial network, and with external partners (contract manufacturing organizations (CMOs), and alliance partners).
Key Responsibilities
The technical writer contributes to various US, EU and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations and other communications with regulatory authorities (e.g., briefing documents for meetings).
He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global locations or contract manufacturing organizations (CMOs), or alliance partners. He/She/They identifies potential regulatory risks/challenges while ensuring Regulatory compliance.
He/she/they authors autonomously the CMC sections of dossiers using templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards. He/She/they ensures delivery of sections in a timely manner.
He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs.
He/she/they performs life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
He/She/They maintains an up to date knowledge of ways of working and SOPs and develops a comprehensive understanding of global CMC regulations and guidelines to enhance probability of regulatory success and regulatory compliance.
He/She/They also authors other types of regulatory documents such as white papers, position papers, and briefing book.
In parallel, the technical writer could help support non regulatory writing projects such as SOP and technical documents throughout the department.
Skills and Experience:
The candidate must possess Chemistry, Manufacturing and Controls (CMC) and CTD experience.
The candidate must have CTD Module 3 authoring skills.
A background of pharmaceutical manufacturing or quality control/quality assurance is a plus.
The candidate must have at least 5 years' experience in the pharmaceutical industry.
Expertise with MS Office, Word, Excel and document management systems such as Veeva or Documentum is a plus. A working knowledge of cGMP’s is desired.
Experience with CMC documentation pertinent to various dosage forms and biological product is a plus.
Excellent interpersonal communication skills are required, and the candidate must have previously demonstrated the ability to interact within a multi-disciplinary team.
The candidate needs very little supervision, is capable of managing their priorities independently, is highly organized, and self-motivated.
The candidate should enjoy writing. Knowledge of US pharmaceutical Regulations is essential.
Exposure to ex-US Regulations is desired, but not mandatory.
Education: BS/BA, MS, or PhD, from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy, or a related field).
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
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. This position’s starting pay is: $46.00/hr.
