Our client is a young innovative clinical stage biopharmaceutical company with a strong development pipeline, now have approval for a new position for SOP Technical Writer who will support Clinical Operations team based in Dublin.
Supporting Clinical Operations activities and oversight / management of vendors, this hire will work closely with the Clinical Trial Managers in developing written procedures in accordance with ICH/GCP regulatory guidelines to support all clinical trials.
This is a six-month contract role and will report to the Head of Clinical Operations. This fast-growing Biopharma company will have opportunity for this hire to progress within Clinical Operations roles, supporting oversight and management of vendor activities.
Responsibilities of SOP Technical Writer:
Lead workflow facilitation of all written procedures for example SOPs, work instructions, policies, forms and other controlled documents, from draft, coordination of review, editing, finalisation, sign off, distribution and training.
Make decisions on retiring old obsolete procedures
Lead and advice the Clinical Operation team on how to be inspection ready, what potential findings could come up in an audit and how these should be addressed in our Written procedures
Requirements for SOP Technical Writer:
Bachelor of Science degree is preferred.
3+ years’ experience working in Clinical Operations the pharmaceutical, biotech or CRO industry, including interpretation and implementation of EU regulations/ICH guidelines, is required.
3 years’ experience writing and developing SOPs for Clinical Operations.
Experience with preparation, facilitation, or management of GCP audits is desirable.
Proven experience with document management systems, e.g. Docusign, Veeva Vault or similar.
Experience in writing Pharmacovigilance written procedures is preferable.
Excellent communicator of technical and scientific information.
Excellent interpersonal skills, strong organization skills and time management skills.
Strong attention to detail is required.
Please contact Larry on +353 1 – 2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
Follow us on Twitter, Facebook and LinkedIn