Senior Medical Writer (Remote - US)
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
Full Stack Java/Scala/DB2 Engineer - Vice President
In the Technology division, we leverage innovation to build the connections and capabilities that power our Firm, enabling our clients and colleagues to redefine markets and shape the future of our c…
Phlebotomist
This is a contract job opportunity. potential for perm Position: Phlebotomist 5251 Location: Albany, NY and area Schedule: M-F 630a-3p every other Sat 7a-11a Projected duration: 3 months + p…
Truck Driver / Operator - CDL A or CDL B
Job Description Job Description Are you looking for a career with a business that places value on their employees? Do you want to work where you are treated as family and not just a number? The…
164. Special Situations Senior Analyst, Credit Investment Desk
Our client, an active credit investment desk in NYC, wants to add Senior Analysts to their successful team. The desk invests across sectors and a variety of credit strategies (special situations, stre…
GM
Position: General Manager Direct Supervisor: Hours: 60 hrs per week Core Responsibilities Culture ● Lead, support, and inspire Team Fini with the core LFG values always in mind (LOVE, …
State and Local Tax Vice President
We’re seeking someone to join our State and Local Tax team as a Vice President in New York Tax to work on compliance and reporting functions. The role will report directly into the Head of Morgan Sta…
Utilization Management Specialist
HealthCare Partners, IPA and HealthCare Partners, MSO together comprise our health care delivery system providing enhanced quality care to our members, providers and health plan partners. Active since…
Food Runner
Soda Club is Overthrow Hospitality’s acclaimed wine + pasta bar in the heart of the East Village at 95 Avenue A. Known for its electric atmosphere, boundary-pushing wine program, and vibrant late-nig…
Certified Nursing Assistant - CNA (Community Living Center)
Overview Ansible Government Solutions, LLC (Ansible) is currently seeking Nursing Assistants (NA) to support the Community Living Center at the Franklin Delano Roosevelt Hospital located at 2094 A…