- 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
- 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
-
Manager, Medical Writing
1 week ago
Pfizer Groton, United StatesROLE SUMMARY- · - Understands the principles of scientific writing, writing with the audience in mind, and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.- Applies comprehensive knowledge of rele ...
-
Sr. Shop Trailer Mechanic
1 week ago
Cox Enterprises Auburn, United StatesCompany: · Cox Automotive - USA · Job Family Group: · Vehicle Operations · Job Profile: · Trailer Repair Technician I · Management Level: · Individual Contributor · Travel %: · No · Work Shift: · Day (United States of America) · Job Description: · * If you have any questions or t ...
-
Customer Care Representative
1 week ago
AMICA MUTUAL INSURANCE COMPANY Westborough, United StatesCustomer Care Representative 1 Research Drive, Westborough, MA 01581 Your future is our business. Our office located in Westborough, MA is seeking a Customer Care Representative. This position involves telephone contact to sell policies and service existing accounts. Candidates s ...
-
Customer Care Representative
1 week ago
Amica Insurance Westborough, United StatesCustomer Care Representative · 1 Research Drive, Westborough, MA 01581 · Your future is our business. · Our office located in Westborough, MA is seeking a Customer Care Representative. This position involves telephone contact to sell policies and service existing accounts. Can ...
-
Amazon Westborough, United StatesThis is a global, highly visible role, and key member of the Mechatronics and Sustainable Packaging, Customer Experience (MSP CX) organization. As a Sr. Program Manager, Business Operations you will be the MSP CX functional leader for business planning, developing and implementin ...
-
Amazon Westborough, United StatesThis is a global, highly visible role, and key member of the Mechatronics and Sustainable Packaging, Customer Experience (MSP CX) organization. As a Manager, Business Operations you will be the MSP CX functional leader for business planning, developing and implementing mechanisms ...
-
Sales & Service Writer
1 week ago
SULLIVAN TIRE COMPANIES Sudbury, United StatesSIGN ON BONUS · Description: · Sullivan Tire, a leading tire and automotive service company, has been family operated for more than 67 years with over 1,200 employees and currently has an opportunity to be a Sales & Service Writer. The Sales and Service Writer will be a custome ...
-
Sales & Service Writer
1 week ago
Sullivan Tire & Auto Service Waltham, United StatesJob Description · Job Description Description: SIGN ON BONUS · Description: · Sullivan Tire, a leading tire and automotive service company, has been family operated for more than 67 years with over 1,200 employees and currently has an opportunity to be a Sales & Service Writer. ...
-
Senior Technical Writer w/Madcap FLARE
1 day ago
Mastech Digital Marlborough, United StatesJob Description · Job DescriptionMastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Technical Writer with MadcapFLARE for our client in the Pharmaceutical domain. We ...
-
Full Time Nabisco Merchandiser/Order Writer
1 week ago
Mondelez International Hudson, United States Full timeJob Description · Join our Mission to Lead the Future of Snacking AT Mondelēz International · Full Time Nabisco Merchandiser/Order Writer · Join our team of Full Time Nabisco Merchandiser/Order Writers and fulfill the merchandising needs of our customers through communication & r ...
-
Full Time Nabisco Merchandiser/Order Writer
14 hours ago
Mondelez International Hudson, United States Full timeJob Description · Join our Mission to Lead the Future of Snacking AT Mondelēz International · Full Time Nabisco Merchandiser/Order Writer · Join our team of Full Time Nabisco Merchandiser/Order Writers and fulfill the merchandising needs of our customers through communication & r ...
-
Head of Medical Writing
5 days ago
Aerovate Therapeutics, Inc. Waltham, United StatesAerovate (AVTE) is a clinical stage biopharmaceutical company focused on developing drugs that meaningfully improve the lives of people with rare cardiopulmonary disease. Our team has spent their careers in cardiopulmonary disease research, drug and aerosol development, commercia ...
-
Brandeis University Waltham, United States Part timePre-Health Advising at Brandeis University is hiring writers to assist in completing letters of recommendation for students applying to medical and dental school. At Brandeis, applicants to these programs must complete a committee process, which includes the submission of written ...
-
Sales & Service Writer
6 days ago
Sullivan Tire & Auto Service Sudbury, United StatesJob Description · Job DescriptionDescription:SIGN ON BONUS · Description: · Sullivan Tire, a leading tire and automotive service company, has been family operated for more than 67 years with over 1,200 employees and currently has an opportunity to be a Sales & Service Writer. The ...
-
Full Time Nabisco Merchandiser/Order Writer
1 week ago
Mondelez International Ashland, United States Full timeJob Description · Join our Mission to Lead the Future of Snacking at Mondelēz International · Full Time Nabisco Merchandiser/Order Writer · Join our team of Full Time Nabisco Merchandiser/Order Writers and fulfill the merchandising needs of our customers through communication & r ...
-
Sr Shop Diesel Mechanic
1 week ago
Cox Enterprises Hopedale, United StatesCompany: · Cox Automotive - USA · Job Family Group: · Vehicle Operations · Job Profile: · Sr Diesel Maintenance Tech · Management Level: · Individual Contributor · Travel %: · No · Work Shift: · Day (United States of America) · Job Description: · * If you have any questions or to ...
-
Shop Diesel Mechanic II
1 week ago
Cox Enterprises Hopedale, United StatesCompany · Cox Automotive - USA · Job Family Group · Vehicle Operations · Job Profile · Diesel Maintenance Tech II · Management Level · Individual Contributor · Flexible Work Option · No remote option; must work at a specified Cox location · Travel % · No · Work Shift · Day · Comp ...
-
Principal Statistical Programmer
1 week ago
Katalyst Healthcares and Life Sciences Hanscom Air Force Base, United StatesResponsibilities: Convert specifications into SAS code to generate datasets and Tables, Listings, and Figures outputs. · Be responsible for overall project delivery, including clinical trial reports and other regulatory submission deliverables. · Create statistical analysis out ...
-
Diesel Mechanic II
7 hours ago
Cox Automotive Mobility Fleet Services Hopedale, United StatesJob Description · Job Description*** If you have any questions or to connect with a recruiter while your application is being reviewed, please Text DFS2 to *** · ****Veterans encouraged to apply**** · Fleet Services – A Cox Automotive Company keeps your fleet moving · Headquart ...
-
Ad and Content Copywriter
1 week ago
Salary Waltham, United States Full timeAre you a dynamic writer with unparalleled expertise in crafting compelling ads and content copy looking to grow your career representing an innovative, fast-growing Would you be excited to be a voice of a leading HR software company? is looking to add a creative, self-motivated ...
Senior Medical Writer - Worcester, United States - MMS
Description
Job Description
Job 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 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 or follow MMS on LinkedIn.
Responsibilities
Requirements
Powered by JazzHR
KP4UTiW8lX