CMC Technical Writer

A top 10 global pharmaceutical company is currently advertising a vacancy for a CMC Technical Writer in their European office. This organisation develops innovative products across multiple therapy areas including cardiovascular, oncology, and respiratory, and employs 100,000 staff globally. Based in the company's office in Middlesex, this position offers an exciting opportunity to work with an internationally renowned company and bolster a career in the clinical field.

Job Responsibilities:

• Writing CMC, "facility and equipment" parts and new files for WW regulatory File.
• Managing and scheduling with SMEs and Site conformance (along with Production, Validation, and Quality Assurance) the writing/review process to ensure timely completion.
• Ensuring the coordination with the departments involved in the writing/review process.
• Writing and supporting regulatory affairs Responses to Questions raised by Regulatory Authorities.
• Monitoring that supportive data provided by other departments is compliant.
• Reporting significant issues.
• Managing the projects within all GSK/GRA tracking tools.
• Assessing the change controls that relate to pure facilities and equipment matters or working with GRL teams for change controls impacting both CMC and facilities.

Skills and Requirements:

• University level degree (Life Sciences background is preferred) or equivalent by experience.
• Experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
• Experience working in validation/QA/production in Biologics/Pharmaceuticals industry.
• Knowledge of regulatory procedures/systems/guidances.
• Good level of spoken and written local language (depending on the location, this will be either French, Italian, or German).
• Knowledge of biologic process and process equipment.
• Knowledge of Qualification/Validation principles.
• ICT Skills (software, operating systems, hardware, etc.).
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

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 contact Numhom Sudsok at +44 203 871 8093 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing 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.

#LI-116605466_NS1

#RegulatoryAffairs