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Technical Writer IPosted by: Makro Scientific
Posted date: Sep-01-2015
Location: Bridgewater, NJ
Contribute to R&D, LCM and Industrial Development and Innovation projects (in-licensing, partnership projects) by planning and delivering agreed Chemistry, Manufacturing and Controls (CMC) submission deliverables for US, EU and rest of world (ROW) registrations for multiple dosage forms.
Create dossier content from source documentation as needed for registrations and writing support for technical reports.
Recommend table of contents for regulatory submissions.
Develop and contribute to regulatory strategy for successful product registration.
Provide 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.
Skills: The candidate must have excellent technical writing and communication skills with a strong background in pharmaceutical manufacturing, regulatory CMC writing or quality control/quality assurance with at least 4 years' experience in pharmaceutical manufacturing or development.
Experience with the common technical document (CTD) templates and electronic document management systems (such as Documentum) are required.
A working knowledge of cGMP's is imperative.
A BS/BA degree is required. Product development and process validation and experience with documentation for parenteral drug manufacturing and testing are a plus.
Experience with API, API DMFs, communicating with API manufacturing sites, and/or API DMF Agents is a plus.
Expertise with MS Word and Excel is necessary.
Experience with MS Visio is a plus.
This position requires the incumbent to be self-motivated and flexible.
The desired candidate will have the capacity to be highly productive with very little supervision.
Excellent interpersonal communication skills are required.
The candidate must have prior experience writing technical reports or investigations with demonstrated experience interacting with multi-disciplinary teams.
Experience with standardized templates and familiarity with regulatory submissions is a desired.
A high level of file management and organizational skills is required.
The ability to communicate using oral and written skills with an excellent knowledge of the English language and strong proofreading and spelling skills is required.
technical writing, CTD, eCTD, API, DMF, cGMP, templates, CTD templates, CMC
MS in Analytical Chemistry or a related field with 4-6 years or Bachelors in Chemistry or a related field with at least 6 years of experience in the Pharmaceutical industry.
Technical writing and communication skills with strong background in pharmaceutical manufacturing, regulatory writing or quality control/quality assurance with at least 4 years experience in pharmaceutical manufacturing or development, obtained by working in a cross-functional team-oriented environment in the pharmaceutical industry.
Working knowledge of cGMP's
Demonstrated ability to interact with a multi-disciplinary team
Experience working with writing template tools
****** ; Important for a candidate to have
Chemistry, manufacturing and controls (CMC) pharmaceutical regulatory writing experience
Really enjoy technical writing
Very organized and detail oriented
Ability to manage multiple priorities