Senior Medical Writer & Project Lead

MMS Holdings Inc; United States; Remote; USD 85,000 - 135,000; Full time

Job summary

MMS Holdings Inc is seeking a skilled Medical Writer to join our regulatory writing team. The role focuses on evaluating literature, developing clinical development documents, and ensuring scientific rigor under regulatory timelines.

The ideal candidate has 3+ years in pharmaceutical regulatory writing, strong MS Word/Excel/PowerPoint skills, and experience leading document production for submissions to authorities.

Qualifications

• 3+ years of previous experience in the pharmaceutical industry
• Must have 3 to 5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelor’s, Master’s, or Ph.D. in scientific, medical, clinical discipline
• Substantial clinical study protocol experience, as lead author, required
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
• Understanding of clinical data
• Exceptional writing skills are a must
• Excellent organizational skills and the ability to multi-task are essential prerequisites
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
• Experience being a project lead, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Not required, but experience with orphan drug designations and PSP/PIPs a plus

Responsibilities

• 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

Skills

Strong writing

Regulatory writing

MS Word

MS Excel

PowerPoint

Project leadership

Education

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

Tools

MS Word

MS Excel

PowerPoint

Job description

MMS Holdings Inc is seeking a skilled Medical Writer to join our regulatory writing team. The role focuses on evaluating literature, developing clinical development documents, and ensuring scientific rigor under regulatory timelines.

The ideal candidate has 3+ years in pharmaceutical regulatory writing, strong MS Word/Excel/PowerPoint skills, and experience leading document production for submissions to authorities.