Senior Medical Writer (Remote)

MMS Holdings Inc; San Jose (CA); Remote; USD 80,000 - 110,000; Full time

Job summary

An innovative firm in the pharmaceutical sector is seeking a skilled Medical Writer to join their dynamic team. In this role, you will critically evaluate medical literature and produce high-quality clinical documents that meet rigorous regulatory standards. Your expertise in regulatory writing and clinical medical writing will be crucial as you lead projects and mentor junior writers. This position offers a unique opportunity to contribute to impactful drug development efforts while working in a collaborative environment. If you are passionate about scientific communication and have a strong background in clinical writing, this role is perfect for you.

Qualifications

• 3-5 years of regulatory and clinical medical writing experience required.
• Expert in MS Office tools and strong organizational skills are essential.

Responsibilities

• Evaluate and interpret medical literature for study design and documentation.
• Write and edit clinical documents including protocols and reports.
• Mentor junior writers and manage project timelines.

Skills

Regulatory Writing

Clinical Medical Writing

Exceptional Writing Skills

Organizational Skills

Communication Skills

Understanding of Clinical Data

Education

Bachelor's Degree in Scientific Discipline

Master's Degree in Scientific Discipline

Ph.D. in Scientific Discipline

Tools

MS Word

MS Excel

MS PowerPoint

Job description

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. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. 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, 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 manage, 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.