Senior Medical Writer (Remote)
Senior Medical Writer (Remote)
Posted on :
31-05-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
31-05-2025
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.
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 more information follow MMS onLinkedIn.
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 more information follow MMS onLinkedIn.
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 investigators 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
- 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
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
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