MMS
Senior ICF Writer (Remote)
The Medical Writer critically evaluates and interprets medical literature to select resource materials for study design and regulatory documents. They write and edit clinical development documents, maintain timelines, and interact directly with clients to coordinate projects while mentoring team members involved in the writing process.
Key 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, Informed Consent Forms and Clinical Protocols
- • 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 communication 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
Required
- • 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 informed consent and clinical study protocol experience, as lead author, required
- • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- • Experienced in understanding complex clinical information
- • Translate complex medical and scientific information into clear, patient-friendly, language
- • Experienced in collaboration and cross-functional communication
- • 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
Preferred
- • Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred
- • 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
Company Overview
Industry: Healthcare Technology
Company Size: 500-1,000 employees
Founded: 2015
Headquarters: San Francisco, CA
Company Links
Key Contacts
Contact information not available
About the Company
Leading healthcare technology company focused on improving patient outcomes through innovative digital solutions. We're transforming the way healthcare is delivered with cutting-edge technology and data-driven insights. Our platform serves over 10,000 healthcare professionals and has processed millions of patient interactions.
Recent News & Updates
Series B
Raised $50M Series B funding - Jan 2024
Award
Named "Best Healthcare Startup" by TechCrunch - Dec 2023
Growth
Expanded to 5 new states - Nov 2023
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.
Roles & Responsibilities
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.
Roles & 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, Informed Consent Forms and Clinical Protocols
- 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 communication 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
- Oncology, General Medicines, Infectious Diseases and Vaccine experience preferred
- Substantial informed consent and clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Experienced in understanding complex clinical information
- Translate complex medical and scientific information into clear, patient-friendly, language
- Experienced in collaboration and cross-functional communication
- 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
Keep track of your job search
Save personal notes for each job to track your thoughts, application status, and follow-ups.
Try for freeUpload your resume
Sign up to upload your resume and get AI-powered customization for job applications.
Sign up freePractice your interview
Get AI-powered mock interviews tailored to this Senior ICF Writer (Remote) role. Upload your resume and practice with real-time voice feedback.
Sign up to practice