Senior Medical Writer — Regulatory Submissions Expert

MMS Holdings Inc

San Diego (CA)

Remote

USD 110,000 - 120,000

Full time

14 days+

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Job summary

MMS Holdings Inc in San Diego, CA is seeking a Medical Writer to critically evaluate literature, draft and edit regulatory documents, and lead writing projects with rigorous timelines. You will interact with clients, mentor teammates, and ensure regulatory standards and templates are followed.

Ideal candidates have 3+ years in pharmaceutical regulatory writing and a strong background in clinical study protocols.

Qualifications

At least 3 years of experience in the pharmaceutical industry.
3-5 years of industry regulatory writing and clinical medical writing experience.
Bachelor's, Master's, or Ph.D. in scientific, medical, clinical discipline.
Substantial clinical study protocol experience as lead author.
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.
Excellent organizational skills and ability to multi-task.
Expert in MS Word, Excel, PowerPoint, and related 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, critically evaluate, analyze, and interpret medical literature to select primary resources for study design, statistical significance, and bias absence.
Write and edit clinical development documents, including protocols, investigator's 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 styles of writing for various regulatory documents.
Expert proficiency with client templates & style guides.
Interact directly with clients to coordinate all facets of projects.
Contribute to or manage production of interpretive guides.
Take ownership of assignments and consult team members for information.
Mentor medical writers and other project team members.