Senior Medical Writer — Regulatory Leader & Mentor

MMS; Atlanta (GA); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

MMS is a data-focused CRO seeking an experienced Medical Writer to craft regulatory and clinical development documents. The role involves leading writing projects, mentoring junior writers, and coordinating directly with clients on study designs and submissions.

The candidate should have 3–5 years in regulatory/clinical writing, strong MS Office skills, and a solid understanding of GCP/ICH guidelines. This is an on-site position in Atlanta, with opportunities to contribute to multi-asset therapy

Qualifications

• 3+ years in the pharmaceutical industry.
• 3-5 years regulatory writing and clinical medical writing.
• Bachelor's, Master's, or PhD in scientific/medical field.
• Lead author for clinical study protocols required.
• Experience with regulatory submissions and clinical study reports is a plus.
• Strong understanding of clinical data and regulatory requirements.
• Exceptional writing and communication skills.
• Excellent organizational and multitasking abilities.
• Expert in MS Word, Excel, PowerPoint and related tools.
• Experience as project lead or managing a project team.
• Knowledge of GCP/ICH guidelines is advantageous.

Responsabilités

• Critically evaluate, analyze, and interpret medical literature for study design and bias.
• Write and edit clinical development documents including protocols and study reports.
• Complete writing tasks in a timely manner and maintain timelines.
• Interact with clients and coordinate project facets with teams.
• Mentor medical writers and project team members.
• Produce interpretive guides and client deliverables.
• Ensure compliance with regulatory templates and style guides.
• Lead and manage document production under tight timelines.
• Communicate effectively with stakeholders to resolve questions.
• Support regulatory submissions and publications to medical journals.

Connaissances

Regulatory writing

Clinical writing

Project leadership

MS Word

MS Excel

MS PowerPoint

Formation

Bachelor's/Master's/PhD in scientific/medical discipline

Outils

MS Word

MS Excel

PowerPoint

Description du poste

MMS is a data-focused CRO seeking an experienced Medical Writer to craft regulatory and clinical development documents. The role involves leading writing projects, mentoring junior writers, and coordinating directly with clients on study designs and submissions.

The candidate should have 3–5 years in regulatory/clinical writing, strong MS Office skills, and a solid understanding of GCP/ICH guidelines. This is an on-site position in Atlanta, with opportunities to contribute to multi-asset therapy