Biologics CMC Writer
Proclinical is currently recruiting for a Biologics CMC Writer for a pharmaceutical company located in Pennsylvania. Successful candidate will be primarily responsible for authoring of CMC sections of global regulatory submissions as well as assisting with other technical documents as needed.
- Contribute to the phase appropriate development strategy for Biologics portfolio.
- Write and edit CMC sections of Regulatory documents that are submitted to Regulatory Agencies worldwide.
- Experience with authoring Module 3 sections for BLA is highly desirable.
- Collaborate with subject matter experts to write and edit d and other manufacturing related controlled technical documents using a uniform style and language for regulatory compliance.
- Coordinate authoring and review activities with the functional areas within Global Biopharmaceutical Development and Quality Assurance to reach alignment and to meet deadlines for Regulatory submissions
- Work closely with and Regulatory Affairs to establish priorities and ensure successful completion of regulatory submissions to Regulatory Operations.
Skills and Requirements:
- BS/MS in Engineering or Biological Sciences or equivalent.
- 3-5 years' experience in technical writing as an SME in Analytical, Formulation, or Process Sciences, with experience in authoring CMC sections of global regulatory filings.
- Proven record on regulatory submissions of biological products. Experience with monoclonal antibody products will be a plus.
- Demonstrate competency in clear and concise technical writing ability.
- Strong communication skill is a must.
- Experience with working collaboratively with other departments such as Technical teams, Quality Assurance and Regulatory Affairs.
- Technical knowledge of monoclonal antibody development is a plus.
- Must be well organized, flexible and able to communicate effectively within CMC functions and Regulatory affairs.
- Must be knowledgeable and worked in biotech related industry.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matt Tong (+1) 646-878-6308 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
A truly global player in the discovery of new molecules are looking to expand their team by recruiting a Senior CMC Project Lead.
€70.00 - €80 per hour
A leading global pharmaceutical company that specialise in the development of biological therapies is advertising a vacancy for a RegCMC Senior Manager position.