CMC Technical Writer
CMC Technical Writer
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1 Vacancy
Job Description
- A Pharmaceutical CMC (Chemistry Manufacturing and Controls) Writer plays a crucial role in regulatory submissions by preparing technical documents related to drug development manufacturing and quality control.
- Authors a range of clinical documents including regulatory documents following defined templates NDA/MAA CTD submission documents investigator brochures briefing documents and responses to regulatory authority questions.
- Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
- Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND BLA or NDA) submissions
- Ensure completion of high-quality submissions following regulatory guidelines and internal processes within timelines
- Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions.
- Assess and communicate potential regulatory risks and propose mitigation strategies
- Understands interprets and advises teams on regulations guidelines procedures and policies relating to manufacture and control of medicinal products to expedite the submission and review and approval of applications.
- Identify communicate and escalate potential CMC regulatory issues as needed
- Help establish regulatory CMC submission processes and procedures.
- Familiar with eCTD format submission files
- Project management skill is plus
- Regulatory Documentation: Author and review CMC sections of regulatory submissions including IND NDA and MAA applications.
- Compliance & Guidelines: Ensure documents align with FDA EMA and ICH regulatory requirements.
- Collaboration: Work closely with scientists regulatory affairs teams and manufacturing experts to gather accurate data.
- Quality Assurance: Maintain consistency clarity and accuracy in technical writing.
- Process Improvement: Help establish regulatory CMC submission processes and procedures.
- Strong technical writing analytical and regulatory knowledge.
- In the pharmaceutical industry and/or pharmaceutical development broad knowledge and understanding of regulatory submissions manufacturing processes analytical methods specifications formulation development test method validation process validation and packaging validation.
- Familiar with a variety of regulatory guidelines technical processes and procedures related to CMC development activities.
- Strong planning and organizational skills with demonstrated ability to deliver work on time.
- Excellent written and communication skills.
- Proficient in the use of Microsoft Office Suite including Word Excel Outlook 365 and Access.
- Education: Bachelors or advanced degree in chemistry pharmaceutical sciences or a related field.
- Experience: Prior experience in pharmaceutical or regulatory writing is preferred.
TekWissen is an emerging global human capital recruitment and IT services organization. Operating since 2009 we draw upon more than a decade of staffing experience to deliver critical talent acquisition solutions and IT engagements for our clients. We re founded on a culture that is passionate about delivering tailored solutions that create lasting partnerships.
Our global footprint covers six countries: United States Canada Australia India United Kingdom and the Philippines. This allows us to work in close partnership with organizations and manage everything from global talent needs with demanding resourcing strategies to single sites with lower recruitment volumes.
TekWissen is an equal opportunity employer supporting workplace diversity.
Employment Type
Full-time
