Laboratory Technical Writer

ABOUT US:
Simbec-Orion is a responsive and agile full-service CRO, with wide therapeutic experience and specialist expertise in clinical pharmacology, oncology and rare diseases. Perfectly structured, we provide full-service clinical development solutions for small and mid-size drug developers - headed up by a centralised leadership team.

With a focus on tailormade and scalable solutions, we’ll adapt our delivery style, communications and operations to suit the demands of the project, helping clients achieve their clinical and commercial objectives. Because our goal is the same as theirs; to improve patients’ lives.

THE ROLE:
We are looking for a Laboratory Technical Writer to join our Laboratory Services team, where you provide specialist skills in technical reports' preparation and quality control procedures in compliance with industry regulations and Standard Operating Procedures (SOPs). You will be responsible for ensuring timelines for assigned technical reports are kept to study timelines and escalate where appropriate if any of these timelines are at risk. In addition, you will assist in the preparation and quality control (QC) checks of study data generated within the LC-MS-MS and Immunoassay teams.

KEY ACCOUNTABILITIES:

- Ensure that work performed adheres to good practice regulations and guidelines.
- Prepare technical reports arising from the scientific work undertaken by the LC-MS-MS and Immunoassay teams.
- Liaise with relevant LC-MS-MS and Immunoassay team members to ensure the rapid, accurate compilation of the documents and provide the Head of Laboratory Project Management with regular updates on their status.
- Escalate to the Head of Laboratory Project Management reporting timelines potentially at risk.
- Assist when required to compile study data and perform Quality Control (QC) procedures from work undertaken by the LC-MS-MS and Immunoassay teams.
- Maintain personal training records to demonstrate competency.
- Where necessary, assist with training and mentoring other laboratory services employees.

SKILLS REQUIRED:
**ESSENTIAL**
- _ Science degree or equivalent experience_
- _ Knowledge of European Medicines Agency (EMA) regulations_
- _ Experience performing Quality Control (QC) procedures_
- _ Experience using Microsoft Office tools, including Word and Excel_
- _ Excellent organisation and time management skills_
- _ Able to write well-constructed, grammatically correct text_
- _ High level of attention to detail and standards_

**DESIRABLE**
- _ Previous experience compiling technical reports in line with European Medicines Agency (EMA) regulations_
- _ Previous experience working in a laboratory environment utilising GLP, GCP, or GMP regulations_

WHY YOU SHOULD JOIN US:
Simbec-Orion is growing fast. To keep up with demand, we’re looking for the best people, from all areas of clinical development, to join our team.

We’re dedicated to bringing the latest advances in science to market. Exposure to truly innovative new drugs in patient populations with serious unmet medical needs is what drives our company - and your reason to be a part of it.

With experts from all disciplines under the same roof, you’ll work alongside some of the industry’s best. So if you’d like to further your career within challenging therapeutic areas in rare disease, oncology, or at our clinical pharmacology site, or laboratory services. We’re waiting to hear from you.