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PreviousExcellent Job Opportunity for the position of CMC Regulatory Technical Writer I (6518832)
Job Title: CMC Regulatory Technical Writer I
Work Location: Bridgewater, NJ
Length of Assignment: 6 Months
Client: A Big Pharmaceutical Company
Provide regulatory assessment of post-approval CMC changes for assigned FDA approved NDA drug products in accordance with current FDA regulations and guidance; author and compile CMC dossiers for NDA supplements, annual reports, phase IV IND, and DMF annual updates for assigned products in eCTD format. Work closely with quality, manufacturing, regulatory and technical staff throughout Client worldwide locations and external manufacturers to communicate, coordinate and track required documentation in support of post-approval CMC activities of the assigned drug products.
Contribute to R&D, LCM, IA, CHC and Industrial Development projects (in-licensing, partnership projects) by planning, writing and delivering agreed submission deliverables for US, EU and rest of world (ROW) registrations for multiple dosage forms. Author and create dossier content from source documentation as needed for registrations and provide writing support for technical reports. Recommend table of contents for regulatory submissions. Develop and contribute to regulatory strategy for successful product registration. Provide and write answers to questions received from regulatory authorities. Create and author dossiers for re-registrations. Ensure all dossiers are in compliance with appropriate SOPs, guidance's, GXP and ICH guidance's and maintain up to date knowledge. Communicate with Quality and manufacturing site teams to request necessary content and documentation for regulatory submissions. Develop and maintain skills required for dossier related software systems used and included in regulatory filings.
The candidate must have excellent Chemistry, Manufacturing and Controls (CMC) technical writing and communication skills with a strong background in pharmaceutical manufacturing, regulatory writing or quality control/quality assurance with at least 7 years' experience in pharmaceutical manufacturing or development. Expertise with MS Office, Word, Excel and Documentum based systems is crucial. Experience with Visio Technical is preferred.
Experience with pharmaceutical and analytical product development, process validation, manufacturing process transfers, change control review for regulatory strategy, along with authoring CMC documentation for oral dosage, parenteral drug, and liquid, ointment and cream manufacturing and testing are desired. A working knowledge of cGMP's is desired. A BS/BA degree in Pharmacy, Chemistry, Biology or science is desired.
This position requires the incumbent to be detail-oriented, highly organized, self-motivated, and able to be flexible and adaptable to juggle multiple priorities. The desired candidate will have the capacity to be productive with very little supervision, committed and enjoy writing. Excellent communication skills are required to work effectively with internal and external partners. Communication to management for activity updates will be required. Knowledge of the US regulatory processes is necessary and exposure to non-US regulatory activities is desired.
Scope of Work:
The candidate must have prior experience writing CMC technical reports or CMC regulatory content or Quality Investigations with a demonstrated ability to interact with a multi-disciplined team. Experience with standardized templates and familiarity with US and International regulatory submissions is desired. The ability to communicate using oral and written skills for clarity, accuracy and conciseness with an excellent knowledge of the English language and strong proofreading and spelling skills is required.
Experienced with change control systems, and authoring and reviewing FDA post-approval CMC changes requiring eCTD format for IND/AR/CBE/Client/NDA/ANDA submissions.
Worked with multi-disciplined teams in the bio-pharmaceutical industry. Lead and managed regulatory CMC projects with internal and external partners.
Excellent communication and technical writing skills. Negotiation skills a plus.
Worked with writing template tools, Documentum based or similar system
Education and Level of Experience:
Working knowledge of cGMP's7 plus years' experience in a pharmaceutical environment including not less than 4 years of experience with CMC regulatory related activities. BS/BA or MS or PhD from an accredited school in a science/health field (e.g. Biology, Analytical Chemistry, Pharmacy or a related field).
In-depth knowledge of USP/Eu. Ph. and Code of Federal Regulations (CFR).
Interested candidates can share their most updated resume at firstname.lastname@example.org or they can reach out to me on #973-967-3412 Ext:3412
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