Cmc Technical Writer

Proclinical are recruiting for a CMC Technical Writer to join a biotech organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

Responsibilities:

• Arrange and offer technical oversight to produce the CMC report of marketing proposals with minimal guidance from management.
• You will arrange the timeline, virtual document and the production of the quality module.
• Take responsibility for business outcomes and solutions, collaborating with some managerial supervision.
• Serve as a representative for the division on multi-functional project development teams to assist on regulatory filings.
• Guarantee all quality proposals are accomplished in a timely manner.
• Review and assure the accomplishment, precision and compliance of data offered for all regulatory proposals with limited guidance from management.
• Other duties may be assigned.

Key Skills and Requirements:

• Knowledge in suitable CMC regulatory applications specifically in authoring dossier for microbial vectors.
• Comprehension of the impact the cumulation of process changes has had on product quality.
• Able to exhibit the DS that will be used for commercial supply of DP is representative that which was used throughout clinical development.
• Solid story boarding of the process development actions and author them in a clear manner.
• Strong DS and DP compatibility review, which involves comparative stability testing.
• Comprehension of historical data assisting crucial development decisions.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at [email protected].

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.

#Regulatory