CMC Technical Writer – DP Drug Product Lyophilization
Aixial Group is a Clinical Research Organization (CRO) specializing in Life Science.
We provide technical support on clinical projects from phases I to IV and post-market, collaborating with laboratories worldwide.
Situated in Basel, Switzerland, we form part of the Alten family since 2014.
We have a strong presence in multiple countries including Switzerland, France, Belgium, Czech Republic, Denmark, UK, and US.
We cater to pharmaceutical, cosmetic, medical device, biotechnology, nutrition, and other industries in clinical operations, regulatory affairs, quality, biometrics, pharmacovigilance, and HEOR.
This role requires a skilled CMC Technical Writer for our DP Drug Product Lyophilization team.
The ideal candidate will possess expertise in creating high-quality documentation for regulatory submissions, lab manuals, and knowledge bases.
Please find below the job description for this position:
Job Description:
This is an opportunity to join Aixial Group's dynamic team as a CMC Technical Writer specializing in DP Drug Product Lyophilization.
You will be responsible for developing clear and concise technical documents that adhere to regulatory requirements.
Your primary focus will be on writing high-quality content for lab manuals, SOPs, and regulatory submission packages.
This role demands attention to detail, excellent communication skills, and the ability to work independently within tight deadlines.
Responsibilities:
* Develop comprehensive documentation for regulatory submissions, lab manuals, and knowledge bases.
* Create high-quality content adhering to regulatory requirements and industry standards.
* Collaborate closely with cross-functional teams to ensure seamless integration of technical documents.
* Conduct thorough reviews of existing documentation to identify areas for improvement.
* Maintain up-to-date knowledge of regulatory guidelines and industry best practices.
Requirements:
* Bachelor’s degree in a relevant field such as Pharmacy, Chemistry, Biology, or related discipline.
* Minimum 2 years of experience in a similar role or relevant industry.
* Excellent written and verbal communication skills.
* Able to work independently and collaboratively within a fast-paced environment.
* Strong attention to detail and organizational skills.
What We Offer:
* A competitive salary package.
* A dynamic and supportive work environment.
* Ongoing training and professional development opportunities.
* Access to cutting-edge technology and resources.