Senior Medical Writer
4 weeks ago
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 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
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
Powered by JazzHR
BuElzf1U24
-
Senior product designer
3 weeks ago
San Francisco, United States Writer Full time✍🏽 About Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy...
-
Senior commercial counsel
3 weeks ago
San Francisco, United States Writer Full timeAbout WriterWriter is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work.Our all-in-one solution makes it easy to deploy customized AI...
-
Enterprise sales leader
5 days ago
San Francisco, United States Writer Full timeAbout WriterWriter is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work.Our all-in-one solution makes it easy to deploy customized AI...
-
Senior commercial counsel
7 days ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI...
-
Senior commercial counsel
4 days ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the worlds leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, LOreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI apps...
-
Senior product marketing manager
1 week ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world's leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L'Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI...
-
Senior commercial counsel
7 days ago
San Francisco, United States Writer Corporation Full timeAbout WriterWriter is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work.Our all-in-one solution makes it easy to deploy customized AI...
-
Senior field marketing
1 week ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world's leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L'Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI...
-
GSI Partnerships lead
1 month ago
San Francisco, United States Writer Full time✍🏽 About Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy...
-
Partner enablement
1 month ago
San Francisco, United States Writer Full time✍🏽 About Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy...
-
Senior Grant Writer
3 days ago
San Diego, California, United States Actalent Full timeJob SummaryWe are seeking a highly skilled Senior Grant Writer to join our team at Actalent. As a key member of our organization, you will be responsible for developing and writing high-quality grant proposals to secure funding for our research initiatives.Key ResponsibilitiesDevelop and write comprehensive grant proposals that meet the requirements of...
-
Senior Grant Writer
2 months ago
San Diego, United States San Diego LGBT Community Center Full timeJob DescriptionJob DescriptionWELCOME TO YOUR CENTER!Established as a community non-profit in 1972, The Center provides targeted programs and services to the full diversity of the San Diego LGBTQ community. The mission of The Center is to enhance and sustain the health and well-being of the lesbian, gay, bisexual, queer, transgender, nonbinary, immigrant,...
-
Senior Grant Writer
4 days ago
San Diego, California, United States Actalent Full timeJob SummaryWe are seeking a highly skilled Senior Grant Writer to join our team at Actalent. As a key member of our organization, you will be responsible for developing and writing high-quality grant proposals to secure funding for our research initiatives.Key ResponsibilitiesDevelop and write comprehensive grant proposals that meet the requirements of...
-
Revenue operations strategy manager
6 days ago
San Francisco, United States Writer Full timeAbout WriterWriter is the full-stack generative AI platform delivering transformative ROI for the world’s leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L’Oreal, and Vanguard to transform the way they work.Our all-in-one solution makes it easy to deploy customized AI...
-
Accounting manager
4 days ago
San Francisco, United States Writer Full timeAbout WriterAI your people will love. That's our vision, and it contains multitudes :-)AIyour peoplewill love.We're filling a big need for generative AI built ground-up for the needs of enterprises and embraced by their teams. As generative AI became a board-level initiative almost overnight for most enterprises, our market matured dramatically and we...
-
Strategic customer success manager
2 months ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world's leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L'Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI...
-
Senior Medical Writer
4 weeks ago
San Jose, United States MMS Full timeJob DescriptionJob DescriptionMMS 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...
-
Demand Writer
1 week ago
San Diego, United States Batta Fulkerson Law Group Full time $18 - $28Job DescriptionJob DescriptionExciting Opportunity to join Batta Fulkerson Law Group as a Full Time Demand Writer in San Diego, CA! Work alongside our team of innovative legal professionals in a fast-paced environment. You'll have the chance to contribute directly to helping our clients and gain valuable experience in the legal field. This position...
-
Senior Technical Writer
2 weeks ago
San Antonio, United States smart techlink Full timeJob DescriptionJob DescriptionHi,Hope you are doing well.Please review the job description and if you are interested. Please do share your updated resume.Role - Senior Technical WriterLocation - San Antonio, TXJob Description:To understand client requirements and lead the delivery of technical solutions ensuring alignment with client requirements and...
-
Customer education specialist
22 hours ago
San Francisco, United States Writer Corporation Full timeAbout Writer Writer is the full-stack generative AI platform delivering transformative ROI for the world's leading enterprises. Named one of the top 50 companies in AI by Forbes, Writer empowers hundreds of customers like Accenture, Intuit, L'Oreal, and Vanguard to transform the way they work. Our all-in-one solution makes it easy to deploy customized AI...
