Senior Medical Writer (Pharmaceuticals)

TL;DR

Senior Medical Writer (Pharmaceuticals): Drafting and editing clinical development documents and regulatory submissions with an accent on scientific rigor and regulatory compliance. Focus on authoring clinical study protocols, integrated safety summaries, and managing the production of interpretive guides.

Location: Remote (Must be based within the UK)

Company

hirify.global is an award-winning, data-focused clinical research organization (CRO) supporting the pharmaceutical, biotech, and medical device industries.

What you will do

• Critically evaluate and interpret medical literature to ensure study design scientific rigor and absence of bias.
• Write and edit clinical protocols, investigator’s brochures, clinical study reports, and integrated safety/efficacy summaries.
• Manage timelines and workflows for writing assignments to ensure timely completion.
• Coordinate directly and independently with clients to manage all facets of project deliverables.
• Mentor junior medical writers and other project team members involved in the writing process.

Requirements

• Must be remotely based within the UK.
• 3-5 years of industry regulatory and clinical medical writing experience within the pharmaceutical industry.
• Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial experience as a lead author for clinical study protocols.
• Expert proficiency in MS Word, Excel, PowerPoint, and related word processing tools.
• Experience leading and managing teams while authoring regulatory documents under aggressive timelines.

Nice to have

• Experience with orphan drug designations and PSP/PIPs.
• Strong understanding of federal regulations, Good Clinical Practices (GCP), and ICH guidelines.
• Experience in regulatory submissions presented to regulatory authorities.

Culture & Benefits

• Great Place to Work certified organization with an exceptional company culture.
• Industry-leading employee retention rate.
• Collaborative and inclusive work environment fostering professional growth.
• Opportunity to work within a global footprint spanning four continents.