J56304CambridgeshireBiotechnology Clinical Medical Affairs PermanentDependent on ExperienceFull Time21/06/2018Regulatory Affairs Regulatory Affairs – Clinical Clinical Development Medical Writing Regulatory Affairs - Biologics Clinical
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We are currently looking for a Clinical Regulatory Affairs Writer to join a leading Drug Discovery company based in the Cambridgeshire area. As the Clinical Regulatory Affairs Writer you will be responsible for advising on, developing, and writing nonclinical and clinical documents for regulatory submission. You will write, edit and manage the documentation preparation process for submission to regulatory authorities.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Regulatory Affairs Writer will be varied however the key duties and responsibilities are as follows:
1. Preparation of pre-clinical and clinical sections for regulatory documentation either by writing new content or making changes/edits to existing content.
2. Co-ordinate and manage review cycles on document revision and finalisation.
3. Ensures document content and style adheres to ICH / FDA / EMEA or other appropriate regulatory guidelines.
4. Evaluate scientific data objectively to describe results and scientific concepts in a concise and accurate manner.
To be successful in your application to this exciting opportunity as the Clinical Regulatory Affairs Writer we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline (e.g Biologic, Molecular Biology, Biochemistry etc.) in addition to hands on experience writing and preparing CTD submissions in a biotechnology / biopharmaceutical / biotherapeutic environment.
2. Proven industry experience in writing clinical and regulatory documents as well as knowledge and understanding of regulatory requirements and guidelines (i.e. ICH / MHRA / FDA).
3. A working knowledge and practical experience in a fast paced environment where accuracy and the ability to analyze, interpret, and communicate data concisely. Excellent grammatical, editorial and proofreading skills is vital.
Key Words: Regulatory Affairs , Medical Writing , Clinical Documentation , Submission , CTD , eCTD , CTA , ICH , FDA , MHRA , Clinical Trials , Clinical Data , IND
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.