- Generate document templates for Analytical Development team.
- Draft reports to support Regulatory filings including IND and BLA dossiers.
- Develop and manage documentation procedures, including good documentation practices, handling and reviewing electronic laboratory notebooks, data and reports.
- Develop and maintain document management systems.
- Provide technical writing support for regulatory documents.
- Collaborate with project leaders and subject matter experts (SMEs) to incorporate feedback into drafting and editing of technical reports.
- Perform review and edits of the documents generated in Analytical Development.
- 3 years of experience with technical publications in a regulated product development environment as a technical writer.
- Experience with writing and reviewing technical documentation.
- Experience with working in a GXP environment.
- Knowledge and experience with HPLC, LC-MS, CE and icIEF methods for biologic products is a plus.
- Knowledge and understanding of the development, commercialization, and life cycle management of biologic products.
- Strong organizational skills.
- Ability to establish relationships with other support areas to gather necessary information. Ability to work effectively in a team environment.
- Attention to detail Ability to work cross-functionally Ability to organize work to meet deadlines.
- Excellent interpersonal and oral/written communication skills, and advanced technical writing for submissions. Experience in regulatory filing and addressing health authority questions is a plus.
- Familiarity with MS Word, Excel, PowerPoint, Outlook and Adobe Acrobat.
- To be considered a BS degree in chemistry, biochemistry or a related area is required; a doctorate level education is preferred.
-
Hybrid - Document Specialist
3 weeks ago
Midas Consulting Atlanta, United StatesShort Description: · Document Specialist Job Description · The Department of Administrative Services (DOAS) State Purchasing Division (SPD) is seeking an experienced document specialist to assist in review and redesign of forms and templates. · Complete Description: · The Dep ...
-
Document Controls Specialist
1 week ago
AtkinsRealis Atlanta, United StatesJob DescriptionWhy join us?It's an exciting time at AtkinsRealis We are rapidly growing in the US. Our company purpose is to build a better world for our planet and its people. We recognize the importance of making sure that our clients and employees, feel this purpose every day. ...
-
Clinical Documentation Specialist
1 week ago
Emory Healthcare Atlanta, United StatesOverview: · Where you matter as much as the work you do · Join Emory Healthcare (EHC) if youre looking for an opportunity with one of the nation's leading Atlanta hospitals in cardiology and heart surgery, cancer, neurology, and more EHC is where those around you are dedicated ...
-
Clinical Documentation Specialist
1 week ago
Emory Atlanta, United StatesWhere you matter as much as the work you do · Join · Emory Healthcare (EHC) · if youre looking for an opportunity with one of the nation's leading Atlanta hospitals in cardiology and heart surgery, cancer, neurology, and more · EHC · is where those around you are dedicated to ...
-
Documentation Specialists
3 weeks ago
CIYIS Atlanta, United StatesWe are seeking a Documentation Specialist to become an integral part of a potential project. The Documentation Specialist will work with our customers and internal delivery team to ensure successful documentation is completed and organized. · Responsibilities: · Lead and/or par ...
-
Stellar Enterprises Sandy, United StatesAbout Us · Who are we? Unique. Germany's leading company in modern wound care. We have over 250 certified nursing staff nationwide in the field and over 100 employees in the office, all working for the well-being of our patients. Who are we missing? Well, you, of course Psst: Acc ...
-
Journeyman Document Management Specialist
5 days ago
9th Way Insignia Atlanta, United States"Company Introduction 9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers so they can achieve their missions. Our specialties include cybersecurity, cloud modernization, software development, data ana ...
-
Food Safety Documentation Specialist
2 weeks ago
Premier Staffing Solution Atlanta, United StatesThe QA Documentation Specialist works directly with the QA Supervisor and QA Manager to ensure product safety and quality programs and systems are met for all products produced. The position manages the documentation function in accordance with organizational policies and goals i ...
-
Document Controls Specialist
1 week ago
AtkinsRéalis Atlanta, United StatesJob Description · Why join us?It's an exciting time at AtkinsRéalis We are rapidly growing in the US. Our company purpose is to build a better world for our planet and its people. We recognize the importance of making sure that our clients and employees, feel this purpose every ...
-
Document Management Specialist
3 weeks ago
NovaWorks Solutions Riverdale, United StatesYour Responsibilities · Responsible for efficient management and organization of documents in a large-scale project · Develop and implement strategies and processes to optimize document management · Ensure compliance with guidelines and standards in document management · Conduct ...
-
Documentation Specialist
3 days ago
Artivion Kennesaw, United States Full timeJob Details · Description · Company Overview: · Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients wit ...
-
T.Y. Lin International Atlanta, United StatesTYLin is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees throughout the Americas, Asia, and Europe, the firm provides suppor ...
-
RIC - Document Review Specialist
3 weeks ago
nLeague Atlanta, United StatesJob Id: 736035 · Position: Document Review Specialist · Department: City of Richmond · Location: 900 E. Broad Street 5th Floor - Room 511 Richmond, VA 23219 · Duration: 12 Months · Job Description: · We are seeking detail-oriented Document Review Specialists to assist in evaluati ...
-
QA Document Control Specialist
3 weeks ago
EPM Scientific Atlanta, United StatesQuality Assurance Document Control Specialist · Company Summary: · A small privately-owned pharmaceuticals CDMO, specializing in generics, is currently seeking a driven, motivated, and multi-faceted QA Document Control Specialist. This role will be located in the greater Atlanta ...
-
Dar Group Atlanta, United StatesTYLin · is a globally recognized, full-service infrastructure consulting firm committed to providing innovative, cost-effective, constructible designs for the global infrastructure market. With over 3,000 employees throughout the Americas, Asia, and Europe, the firm provides sup ...
-
Remote Engineering Documentation Specialist
2 weeks ago
Global Channel Management Atlanta, United StatesJob Description: · Remote Engineering Documentation Specialist needs technical writing experience · Remote Engineering Documentation Specialist requires: · Technical writing ability to understand the operation of products and transform that understanding into readable technical ...
-
Junior Document Management Specialist
2 days ago
9th Way Insignia Atlanta, United States"Company Introduction 9th Way Insignia is a service-disabled, veteran-owned small business bringing transformative technology to our government customers so they can achieve their missions. Our specialties include cybersecurity, cloud modernization, software development, data ana ...
-
clinical documentation improvement specialist
4 weeks ago
Emory Healthcare/Emory University Atlanta, GA , USA, United States**Overview** · **Heart. Soul. Expertise.** That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-des ...
-
clinical documentation improvement specialist
3 weeks ago
Emory Healthcare Atlanta, GA , USA, United StatesOverview · Heart. Soul. Expertise. That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-designated ...
-
clinical documentation improvement specialist
3 weeks ago
Emory Atlanta, GA , USA, United StatesHeart. Soul. Expertise. That's what defines an Emory Employee. No matter where you are in your Healthcare career, when you chose this distinguished profession, you chose to change lives. Emory Healthcare is the only health system in Georgia with four Magnet-designated hospitals a ...
Documentation Specialist II - Atlanta, United States - US Tech Solutions, Inc.
Description
Job Title: Documentation Specialist II
Location: Remote
Duration: 12 months contractwith possible extension
Job Description:
Searching for a highly motivated individual to fill the Documentation Specialist role in the Analytical Development Department. The Analytical Development Department is responsible for analytical method development, method qualification and transfer to QC, and execution of analytical methods to provide product and process understanding, as well as analytical CMC program management.
Responsibilities:
Experience:
Skills:
Education:
