Remote CMC Technical Writer wanted | $150 per hour

COMPANY/PUBLICATION: G&L HEALTHCARE ADVISORS

G&L Healthcare is currently looking for candidates who have experience writing technical reports based on product development and testing. These technical reports will form the foundation or source data for an eventual BLA.

This work is upstream from regulatory authoring and does NOT involve authoring CTD section content for the BLA. Rather, this CMC technical writer will be responsible for authoring study reports based on raw data, working with the client’s SMEs at their CMO, in preparation for the BLA. The candidate requirements are similar to a regulatory technical author but will need to be more scientifically focused and familiar with the content/ format of a report that will be the basis for BLA CTD section content. More details below:

• Product is an Enzyme Fusion Molecule, which is a complex biologic product
• Workload may be gradual at first, ramping up from the onboarding, planning and TOC design phase, to full time.
• Through end of 2023
• G&L’s technical writer will need to work closely with client scientists/ technical team, to help guide and write the technical reports
• West Coast preferred, but anywhere in the US is fine, as long as they can accommodate working west coast hours (meaning up to 4pm pacific/ 7pm east coast)
• Strong analytical development background preferable, although not essential
• Experience with authoring BLA module 3/ 2.3 CMC content is a plus, but not essential.

G&L Healthcare Advisors is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.

We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.

G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.

CONTACT INFORMATION:

Original job posting: Click here

Website: https://www.gandlhealth.com

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