Regulatory Medical Writer
G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.
As demand for our services and solutions continues to increase, we have an exciting new opportunity for a Regulatory Medical Writer to join our global team.
This permanent role is available globally.
- Authoring and preparing clinical and regulatory documents, including:
- Investigator’s Brochures,
- Study Protocols/ Informed Consent Forms (ICF),
- General Investigational Plan,
- Non-clinical Overviews (CTD section 2.4),
- Clinical Overviews (CTD Section 2.5),
- Non-clinical Summaries (CTD Section 2.6),
- Clinical Summaries (CTD Section 2.7),
- Paediatric Investigation Plans,
- Orphan Drug Designations,
- Clinical Study Reports (CSR), ISS and ISE,
- PSUR/ DSUR.
- A BSc degree with relevant writing experience or a BA degree with relevant scientific/medical knowledge and expertise.
- A minimum of ten (10) years’ experience in medical writing.
- Extensive skills in English grammar, FDA and ICH regulations and guidelines and AMA style guide.
- A demonstrable, high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
- Strong proficiency in all Microsoft products including the ability to solve technical problems with Word templates.
- Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information.
- A solid understanding of drug development processes, preclinical development, toxicology etc.
- Experience with effectively managing and meeting timelines/project objectives.
- Expertise in multiple therapeutic areas.
For further details, please send your CV to: firstname.lastname@example.org
G&L Scientific 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.
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