Senior Medical Writer (Remote)
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 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
- 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
Recommended Jobs
RNs $50/hour- day and overnight shifts
Location: Paterson, NJ 07501 Date Posted: 10/31/2025 Category: Nursing Education: None Per diem RN needed for Drug and Alcohol facility in Paterson, NJ. Morning and overnight shifts avai…
Licensed Practical Nurse
Licensed Practical Nurse (LPN) Currently looking for EXPERIENCED Licensed Practical Nurse(s) (LPN) to fill multiple openings with a home care agency located in Raritan, NJ. Interested candidates sho…
Dental Hygienist
Job Description Job Description The office of Joseph T. Buzzanco is currently seeking a part-time Registered Dental Hygienist for Tuesdays and Fridays from 8am to 5pm. We offer competitive wages,…
Technical Systems Engineer
Becoming a Key Player as a Technical Systems Engineer Imagine powering through your workdays as a Technical Systems Engineer , where your focus is on ensuring flawless operations and unmatched sys…
Entry Level Sales Team Member
Ascension Management, a rapidly expanding sales and marketing firm in New Jersey, is looking for a passionate individual to join our team as an Entry Level Sales Team Member. This is an exceptional …
Principal Biostatistics Data Scientist
Principal Biostatistics Data Scientist About Character Biosciences Character Biosciences is a precision medicine company pioneering targeted therapies for polygenic diseases, with an initial fo…
Watchmaking Apprentice
TAG Heuer is offering a one-year paid Watchmaking Apprenticeship in Springfield, USA. This full-time program provides comprehensive training in watch repairs, including theoretical and practical sessi…