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.

Summary of the Position:

We are looking for a Senior Technical Writing Associate to join our Regulatory Affairs and Technical Writing department. You will be based remotely in the UK.

You will be responsible for the research, writing and editing of Technical Writing (TW) and Regulatory documents with a focus on Clinical Study Reports (CSRs) and Clinical Study Protocols for all Simbec-Orion projects whilst ensuring compliance to ICH-GCP, other industry regulations and Standard Operating Procedures (SOPs).

Key Accountabilities:

• Prepare, review and quality control (QC) Technical Writing and Regulatory documents, including Clinical Study Reports (CSRs), Patient Narratives, Clinical Study Protocols, Case Record Forms (CRFs), Investigator Brochures (IBs), Statistical Analysis Plans (SAPs) and other supportive Clinical Development Documentation.
• Provides writing support to all project Aggregate Reports that are written in collaboration with the client and internal project stakeholders;
• Reports on Development Safety Update Report (DSUR)/Periodic Safety Update Report (PSUR) to clients and project team within agreed/regulatory timelines.
• Act as Technical Writing lead for designated complex global and early phase clinical trials.
• Provide input in data analysis interpretation (e.g., to produce relevant CSR result sections).
• Maintain TW project tracking systems by incorporating all relevant information or supply relevant information regarding TW project status to TW Management to maintain TW status reports, as required.
• Assist Project Managers with month-end financial reporting on their projects.
• Supervise and mentor less experienced Technical Writing team members.
• Perform other duties as assigned by Regulatory Affairs & Technical Writing management team such as developing and writing SOP's, assisting in Business Development activities etc.

Minimum Requirements:

Essential:

• Bachelor's degree within Science or medical field or equivalent
• Extensive experience authoring, editing and managing Clinical Study Reports (CSR's), clinical protocols and or other types of regulatory/ clinical documents.
• Familiar with clinical trial methodology, statistical principles/concepts used in clinical research.
• Excellent analytical, planning, investigative and problem-solving skills
• Excellent understanding of technical writing within an ICH-GCP environment Excellent command of the English language (written and oral) as well as a local language where applicable
  
  

Desirable:

• Advanced degree (Masters, PhD) or equivalent
• Experience in writing medical/regulatory or publication of reports in a full-service CRO
• Experience in the interpretations of statistical analysis
• Fluent in another European language

Simbec-Orion Job Profile - Senior Technical Writing Associate.pdf

Simbec-Orion is an equal opportunity employer. Simbec-Orion will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.