Senior Medical Writer (Remote - US)

MMS; San Diego (CA); On-site; USD 110,000 - 120,000; Full time

Job summary

MMS is a global CRO focused on data-driven regulatory writing for pharmaceutical clients. The Medical Writer will evaluate literature, draft protocols, study reports, consent forms, and safety summaries, ensuring scientific rigor and regulatory compliance.

With 3+ years in regulatory writing, you will mentor junior writers, coordinate with clients, and manage timelines under tight schedules. Strong MS Word and presentation skills are essential in a collaborative, fast-paced environment in San

Qualifications

• At least 3 years of experience in the pharmaceutical industry.
• 3-5 years of regulatory writing and clinical medical writing experience.
• Bachelor/Master/PhD in scientific, medical, or clinical discipline.

Responsibilities

• Under minimal supervision, evaluate, analyze, and interpret medical literature to select primary materials for study design, statistical significance, scientific rigor, and absence of bias.
• Write and edit clinical development documents including protocols, investigator's brochures, clinical study reports, consent forms, integrated safety and efficacy summaries, Module 2.7.x documents, presentations, and journal publications.
• Complete writing assignments in a timely manner and maintain timelines and workflows.
• Mentor medical writers and other project team members involved in the writing process.

Skills

Regulatory writing

Medical writing

Project leadership

Interpersonal communication

MS Word

MS Excel

PowerPoint

Regulatory submissions

Education

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

Tools

MS Word

MS Excel

PowerPoint

Job description

About MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

About MMS

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger.

For more information, visit www.mmsholdings.com or follow MMS on LinkedIn.

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

Requirements

• At least 3 years of previous experience in the pharmaceutical industry
• Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
• The ideal candidate would hold a Bachelors, Masters, 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

Salary Range

$110 000 - $120 000 average per annum, with flexibility to go above, depending on the successful candidate’s level of experience, skills, and qualifications. Salary expectations will be discussed further during interviews.