Senior Medical Writer — Regulatory Submissions Expert

MMS; Raleigh (NC); Vor Ort; USD 90.000 - 125.000; Vollzeit

Zusammenfassung

MMS is a data-focused CRO seeking an experienced Medical Writer to analyze medical literature, develop regulatory documents, and ensure scientific rigor in study materials. You will draft protocols, study reports, and safety summaries, coordinating with clients and project teams on timelines.

The role requires leadership in writing projects, experience with regulatory submissions, and strong MS Office skills, with collaboration across cross-functional teams to deliver compliant documents.

Qualifikationen

• Minimum 3 years of regulatory/clinical writing experience.
• Experience with regulatory submissions is a plus.
• Strong MS Word/Office skills.

Aufgaben

• Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
• Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
• Complete writing assignments in a timely manner
• Maintain timelines and workflow of writing assignments
• Practice good internal and external customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with client templates & style guides
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
• Contribute substantially to, or manages, production of interpretive guides
• Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
• Mentor medical writers and other members of the project team who are involved in the writing process

Kenntnisse

Regulatory writing

Medical writing

Project leadership

MS Word

MS Excel

PowerPoint

Clinical study protocols

Regulatory submissions

ICH guidelines

Attention to detail

Communication skills

Ausbildung

Bachelor’s/Master’s/PhD in life sciences

Tools

MS Word

MS Excel

PowerPoint

Jobbeschreibung

MMS is a data-focused CRO seeking an experienced Medical Writer to analyze medical literature, develop regulatory documents, and ensure scientific rigor in study materials. You will draft protocols, study reports, and safety summaries, coordinating with clients and project teams on timelines.

The role requires leadership in writing projects, experience with regulatory submissions, and strong MS Office skills, with collaboration across cross-functional teams to deliver compliant documents.