Senior Medical Writer — Regulatory Submissions Expert

MMS; Bridgeport (CT); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

MMS is seeking a skilled Medical Writer to join our regulatory writing team in Connecticut. You will analyze literature, draft protocols, study reports, informed consent forms, and safety summaries, ensuring scientific rigor and regulatory alignment.

You will mentor junior writers, manage timelines, and interact with clients to coordinate deliverables. A strong background in clinical development and regulatory submissions is essential for success at MMS.

Formación

• At least 3 years in the pharmaceutical industry.
• 3–5 years regulatory writing and clinical medical writing experience.
• Bachelor/Master/PhD in scientific/medical discipline.
• Substantial clinical study protocol experience as lead author.
• Experience leading teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions presented to authorities is a plus.
• Understanding of clinical data.
• Exceptional writing 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 federal regulations, GCP, and ICH guidelines is a plus.
• Orphan drug designations and PSP/PIPs a plus.

Responsabilidades

• Critically evaluate, analyze, and interpret literature to select primary materials for study design and bias absence.
• Write and edit clinical development documents: protocols, brochures, study reports, consent forms, safety summaries, modules, and publications.
• Complete writing assignments in a timely manner.
• Maintain timelines and workflow of writing assignments.
• Practice good internal and external customer service.
• Proficient with client templates & style guides.
• Interact directly with clients to coordinate all project facets.
• Contribute to or manage production of interpretive guides.
• Take ownership of assignments and consult team members as needed.
• Mentor medical writers and project team members involved in writing.

Conocimientos

Regulatory writing

Clinical writing

Project leadership

Team mentoring

ICH guidelines

Regulatory submissions

Clinical data knowledge

Excellent writing

Educación

Bachelor/Master/PhD in scientific field

Herramientas

MS Word

MS Excel

PowerPoint

Descripción del empleo

MMS is seeking a skilled Medical Writer to join our regulatory writing team in Connecticut. You will analyze literature, draft protocols, study reports, informed consent forms, and safety summaries, ensuring scientific rigor and regulatory alignment.

You will mentor junior writers, manage timelines, and interact with clients to coordinate deliverables. A strong background in clinical development and regulatory submissions is essential for success at MMS.