CMC Technical Writer

Job title:

CMC Technical Writer

Company

HRM Recruitment

Job description

Job descriptionOur client is an innovative pharmaceutical and biotech organisation focused on health and nutrition, developing and marketing products that address and support nutritional deficiencies in patients.They now require a CMC Technical Writer, to join their growing team based out of Dublin, working remotely from the beginning with the flexibility to travel to and from their operations in Milan when required. This is a really exciting role that offers a unique opportunity for someone who is eager to contribute to the early stages of bringing an innovative drug product to market, playing a key part in shaping its success and regulatory approval.The Position

• Write and review technical documents (development reports, protocols, study reports).
• Author and compile regulatory documents (CMC sections).
• Assist in developing and updating regulatory filings, including master files, technical files for medical devices, and CTDs for drug approvals.
• Establish and maintain a document management system.
• Collaborate with cross-functional, international teams for input and feedback.

The Person

• PhD or Master’s in science (Chemical Engineering, Chemistry, Bio-Chemistry, Pharmacy, or related field).
• 3+ years of experience in GMP manufacturing or CMC writing.
• Knowledge of CMC processes, including drug substance/product manufacturing, stability, analytical and formulation development.
• Ability to convert technical information into regulatory-compliant documentation.
• Strong communication, planning, and organizational skills.
• Able to manage multiple tasks independently in a fast-paced environment.
• Fluent in English.

The Benefits

• Competitive Market Salary.
• Significant career growth and opportunities.
• Comprehensive benefits package.

To learn more about this opportunity, apply online or contact Treasa Prior at HRM Search Partners at +353 873983226, for a confidential discussion.

Expected salary

€70000 per year

Location

Dublin

Job date

Thu, 26 Sep 2024 07:47:15 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.org) you saw this job posting.