Job Title: Senior Regulatory Medical Writer
We are seeking an experienced Senior Regulatory Medical Writer, with a strong background in clinical trials and regulatory affairs, to join our team. The successful candidate will be responsible for the authorship, review and management of clinical documents such as protocols, investigator brochures, clinical study reports and summaries.
Key Responsibilities:
* Liaise with medical/clinical experts during document development;
* Update clinical and non-clinical regulatory documents throughout their lifecycle;
* Draft briefing packages and applications to authorities;
* Oversight publication of key guidelines within relevant diseases and support internal training.
Qualifications & Experience Requirements:
☐ A degree in Life Sciences;
☐ Advanced qualifications preferred (PhD or Post Doctorate);
☐ 5+ years' experience in Pharma/Biotech industry;
☐ 2 years as a Regulatory Medical Writer / similar role.
Bonus Points if you have: ----------------------------------- experience preparation clinical components filings NDA BLA MAA/',