Medical Writer jobs in Georgia
Recently Added Medical Writer jobs
Senior Medical Writer (Remote)
- RemoteWorker US
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Athens, GA
FULL_TIME
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Job Description
Job Description
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, 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
fwj7QvUfqO - 7 Days Ago
Senior Medical Writer (Remote)
- MMS
-
Athens, GA
FULL_TIME
- 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 chall...
- 9 Days Ago
Senior Medical Writer (Remote)
- MMS
-
Marietta, GA
FULL_TIME
- 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 chall...
- 19 Days Ago
Senior Regulatory Technical Writer (Hybrid)
- Avanos Medical
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Alpharetta, GA
FULL_TIME
- Requisition ID: 5914Job Title: Senior Regulatory Technical Writer (Hybrid)Job Country: United States (US)Here at Avanos Medical, we passionately believe in three things:Making a difference in our prod...
- 1 Day Ago
Service Writer
- Auto Systems Centers Inc (Katz Midas Group)
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Fayetteville, GA
FULL_TIME
- Auto Systems Centers is an Employee owned company (ESOP) and is also the worlds largest Midas Franchisee in the Midas chain. Every Team member receives company stock (after first full fiscal year) eve...
- 2 Days Ago
Computing Writer
- Android Police
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Atlanta, GA
CONTRACTOR
- This position will operate on a remote, freelance basis. Applicants must be located in the US or Canada.Are you an experienced blogger with a knack for cutting through the fat and extracting the beati...
- 2 Days Ago
Medical Writer jobs at Popular Companies
Medical Writer
- JCW
-
Irvine, CA
- Apply for an exciting opportunity to join a global Medical Device company. You will be writing many CERs for existing pr...
- 6/10/2024 12:00:00 AM
Medical Writer
- Randstad Life Sciences US
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- Title: Medical Fact Checker Location: Remote | Based in IL Pay: $60-64/hr Contract: 12+ months Summary The Fact Checker ...
- 6/10/2024 12:00:00 AM
Senior Medical Writer
- Intellectt Inc
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- Role: Senior Medical Writer Location: Remote role Duration: Long Term Essential Duties and Responsibilities: • With over...
- 6/10/2024 12:00:00 AM
Medical Writer
- Total Package Professional Services
-
San Diego, CA
- Under the general direction of the Medical Strategy Lead, the Medical Writer plays a critical role in creating accurate,...
- 6/10/2024 12:00:00 AM
Senior Medical Writer
- 9992
-
Cambridge, MA
- Job Description Job Description Supervise regulatory writing vendors to manage submission documents and ensure the scien...
- 6/10/2024 12:00:00 AM
Scientific Medical Writer
- Oklahoma Medical Research Foundation
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Oklahoma City, OK
- Overview: The Oklahoma Medical Research Foundation (OMRF) is an independent, not-for-profit, biomedical research institu...
- 6/10/2024 12:00:00 AM
Senior Medical Writer
- EPM Scientific
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- PhD preferred 10+ years medical writing experience worked on sponsor side of the business Hybrid role (2 days on-site) B...
- 6/8/2024 12:00:00 AM
Principal Medical Writer
- Meet
-
Chicago, IL
- Principal Medical Writer Job Description: Meet's partnered with a top 10 pharma who is looking for an enthusiastic and p...
- 6/8/2024 12:00:00 AM
About Georgia
Georgia is a state in the Southeastern United States.Beginning from the Atlantic Ocean, the state's eastern border with South Carolina runs up the Savannah River, northwest to its origin at the confluence of the Tugaloo and Seneca Rivers. It then continues up the Tugaloo (originally Tugalo) and into the Chattooga River, its most significant tributary. These bounds were decided in the 1797 Treaty of Beaufort, and tested in the U.S. Supreme Court in the two Georgia v. South Carolina cases in 1923 and 1989.
The border then takes a sharp turn around the tip of Rabun County, at latitude 35°N, thou...
Source: Wikipedia (as of 04/17/2019). Read more from Wikipedia
Income Estimation for Medical Writer jobs
$86,959 to $107,376
Most Popular Cities in Georgia for Medical Writer Jobs
What does a Medical Writer do?
Medical Writer
Attend on-site client meetings, listening to their needs, offering your feedback, and building a level of trust that will ensure future commitments.
April 21, 2023
Negotiates with cross-functional areas on project outcomes and deliverables to meet conflicting demands.
April 15, 2023
Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
January 27, 2023
Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
December 31, 2022
Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for as
November 22, 2022
Medical Writer in Virginia Beach, VA
Functional knowledge of Biostatistics - Accurate description and presentation of clinical trial methods, statistical parameters, and medical data.
January 27, 2023
Medical Writer
Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio.
May 02, 2023