CMC Technical Writer- Senior Manager (Microbial Vector)
CPL Life Sciences have partnered up with an established biopharmaceutical company that have a main focus and target on rare diseases. This company is currently on the look out for a CMC Technical Writer to join their team.
Location: Remote (must be able to travel abroad for meetings)
Salary: Attractive hourly rate (Negotiable dependent on experience).
Working hours: Full time
Contract Length: January- October (extension to contract is an option)
Job role
- Developing the technical eCTD sections to support Regulatory CMC dossier applications.
- Coordinate and provide technical oversight for the generation of the CMC dossier of marketing submissions.
- Coordinate the timeline, virtual document and the generation of the quality module.
- Take ownership and responsibilities for business results and solutions.
- Represent department on multifunctional project development teams to support regulatory filings.
- Technical expertise in writing dossier for microbial vectors.
- Make sure regulatory submissions are compliant, complete and accurate.
- Support technical functions in development of responses to health authority inquiries in support of major applications.
Requirements
- Relevant PhD with Post-doc experience with 6 years+ experience.
- Or University degree with 8 years + experience.
- Individual must have experience writing a BLA.
- Must be able to take ownership of a BLA.
- Must have have been involved in writing the dossier from start to BLA section.
- Ability to work with limited supervision from superior.
If you feel your experience and skillset match with this job role, please feel free to apply or contact me for further information.
Email address: [email protected]