Senior Medical Writer (Remote - US)

MMS; New York (NY); On-site; USD 110,000 - 120,000; Full time

Job summary

MMS, a data-focused CRO, seeks an experienced Medical Writer in New York to critically evaluate literature, select materials for study design, and prepare regulatory documents. You will write and edit protocols, investigators’ brochures, study reports, consent forms, safety summaries, and modules to regulatory standards.

You will mentor team members, coordinate with clients to ensure timely delivery, and maintain high quality across multiple documents while adhering to strict timelines.

Qualifications

• 3+ years of experience in pharmaceutical industry with regulatory writing focus.
• 3–5 years of industry regulatory writing and clinical medical writing experience.
• Bachelor’s, Master’s, or Ph.D. in scientific/medical discipline preferred.
• Substantial clinical study protocol experience as lead author required.
• Experience leading and managing teams with aggressive timelines for regulatory documents.
• Experience in regulatory submissions (clinical study reports) a plus.
• Understanding of clinical data and strong writing skills.
• Excellent organizational skills and multitasking abilities.
• Expert in MS Word, Excel, PowerPoint, and related tools.
• Project leadership experience or managing a project team.
• Knowledge of federal regulations, GCP, and ICH guidelines is a plus.
• Orphan drug designations and PSP/PIPs experience a plus

Responsibilities

• Critically evaluate, analyze, and interpret literature to select primary materials for study design, statistical significance, and bias-free reporting.
• Write and edit regulatory documents including protocols, investigator’s brochures, study reports, consent forms, safety summaries, and module documents.
• Maintain timelines and ensure timely completion of writing assignments.
• Internally and externally communicate with clients to coordinate projects and maintain high service levels.
• Mentor junior writers and project team members involved in writing processes.

Skills

Regulatory writing

Clinical medical writing

Team leadership

Editing & proofreading

Client communication

MS Word proficiency

MS Excel

PowerPoint

Education

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

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.