Job Information
Adecco US, Inc. USA Technical Writer II Manufacturing Quality 1st Shift in Bridgewater, New Jersey
Adecco Healthcare & Life Sciences is hiring a contract Technical Writer for our Pharmaceutical partner in Bridgewater, NJ.
The anticipated wage for this position is between $48 and $49.65. Hourly wage may depend upon experience, education, geographic location, and other factors.
Benefit offerings include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pay upon meeting eligibility criteria
Technical Writer One-Year Contract
• 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: VEEVA, life-cycle tools, MS Suite especially Word & Excel • Preferred experience: Regulatory affairs • Work Experience: 5 years of industry experience
In person or Remote (East Coast with initial training onsite at Bridgewater, NJ and few days for the first few months)
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 the 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).
Pay Details: $48.00 to $49.65 per hour
Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.
Equal Opportunity Employer/Veterans/Disabled
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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.