Current jobs related to Nonclinical Regulatory Writer | DMPK - New York, New York - Axelon Services Corporation
-
Technical Writer
1 month ago
New York, New York, United States ProMach Full timeJoin Our Team as a Technical WriterWe are seeking a skilled Technical Writer to create high-quality documentation for our packaging automation solutions. As a Technical Writer, you will be responsible for developing user manuals, guides, and other technical documents to ensure our customers have the information they need to successfully operate and maintain...
-
Senior Medical Writer
3 weeks ago
New York, New York, United States Genmab Full timeAbout the RoleWe are seeking a highly motivated and collaborative Associate Director, Medical Writing to join our team at Genmab. As a key member of our Medical Writing department, you will play a critical role in planning, developing, and writing complex clinical documents to support medical and regulatory activities across our portfolio.Key...
-
Medical Writer Manager
4 weeks ago
New York, New York, United States Pfizer Full timeJob SummaryPfizer is seeking a highly skilled Medical Writer Manager to join our team. As a key member of our medical writing team, you will be responsible for creating high-quality documents that support clinical studies and regulatory interactions.Key ResponsibilitiesDevelop and maintain project timelines, ensuring timely delivery of documents.Collaborate...
-
Certified Trauma Registrar
4 weeks ago
New York, New York, United States AtlantiCare Full timeTrauma Registrar Role:The Trauma Registrar is responsible for collecting, entering, and maintaining data for regulatory agencies. Utilizing critical thinking and analytical skills, the registrar will analyze and interpret patient data to determine coding classifications, including ICD-10 diagnosis and procedure coding, E-codes, and AAAM...
-
Care Management Support Coordinator II
2 weeks ago
New York, New York, United States BCforward Full timeJob Title: Care Management Support Coordinator II Job Summary: BCForward is seeking a highly skilled Care Management Support Coordinator II to join our team. As a key member of our care management team, you will play a vital role in facilitating effective communication and coordination between members, providers, and staff. Key Responsibilities: * Conduct...
-
Customs Entry Specialist
3 weeks ago
New York, New York, United States Altius Talent | Freight Forwarding Recruitment Full timeCustoms Entry WriterWe are seeking a skilled Customs Entry Writer to join our client's expanding team in New York City. As a key member of the customs brokerage team, you will be responsible for facilitating customs clearance for international shipments, ensuring compliance with all customs regulations, including FDA, EPA, and Lacey Act requirements.Key...
-
Medical Content Specialist
4 weeks ago
New York, New York, United States Precision Medicine Group Full timeAbout the RoleWe are seeking a highly skilled Medical Writer to join our team at Precision Medicine Group. As a Medical Writer, you will play a critical role in developing high-quality scientific content that improves patient outcomes.Key ResponsibilitiesDevelop client-ready drafts of content in various forms, including slide decks, executive summaries, and...
-
Customs Entry Specialist
4 weeks ago
New York, New York, United States Altius Talent | Freight Forwarding Recruitment Full timeCustoms Entry WriterAltius Talent | Freight Forwarding Recruitment is seeking a skilled Customs Entry Writer to join our client's expanding team in New York City.About the RoleThis vital position involves facilitating customs clearance for international shipments, ensuring compliance with all customs regulations, including FDA, EPA, and Lacey Act...
-
Customs Entry Specialist
3 weeks ago
New York, New York, United States Altius Talent | Freight Forwarding Recruitment Full timeCustoms Entry WriterAbout the Role:Altius Talent, a leading recruitment agency in the freight forwarding industry, is seeking a skilled Customs Entry Writer to join our client's team in New York City. As a key member of the customs brokerage team, you will play a vital role in facilitating customs clearance for international shipments, ensuring compliance...
-
Customs Clearance Specialist
4 weeks ago
New York, New York, United States Altius Talent | Freight Forwarding Recruitment Full timeCustoms Entry WriterLocation: New York City, USAAbout Us:As a leading recruitment agency in the freight forwarding industry, Altius Talent connects industry leaders with exciting new opportunities, driving growth and innovation in the logistics sector.Position Summary:We are seeking a skilled Customs Entry Writer to join our client's expanding team in New...
-
Clinical Editing Director
4 weeks ago
New York, New York, United States argenx Full timeTransform Immunology and Deliver Life-Changing MedicinesAt argenx, we're pushing the boundaries of biotechnology to develop innovative treatments for autoimmune diseases. As an Associate Director of Clinical Editing, you'll play a crucial role in ensuring the accuracy and quality of our clinical and regulatory submission documents.Key...
-
Senior Property Underwriter
2 weeks ago
New York, New York, United States Zurich Insurance Group Full timeAbout the RoleZurich is seeking an experienced Senior Property Underwriter to join our National Accounts Construction team in our New York office.Key ResponsibilitiesUnderwrite property insurance policies for complex construction projectsCollaborate with underwriters, writers, and other stakeholders to ensure accurate and timely policy issuanceDevelop and...
-
Certified Trauma Registrar
5 days ago
New York, New York, United States AtlantiCare Full timeTrauma Registrar Role:The Trauma Registrar, utilizing critical thinking, is responsible for the collection, entry, maintenance, and reporting of data for the appropriate regulatory agencies. This position assumes direct responsibility for accuracy, completeness, confidentiality, and data entry of information collected in compliance with the American College...
-
Legal Counsel
3 weeks ago
New York, New York, United States Jane Street Full timeAbout the PositionWe are seeking a skilled junior attorney to join our growing Legal and Compliance department at Jane Street. As a key member of our transactional team, you will assist various business groups in drafting and negotiating complex agreements and advising on legal and regulatory matters.ResponsibilitiesNegotiate and draft a wide range of...
-
Legal Counsel
3 weeks ago
New York, New York, United States Jane Street Full timeAbout the PositionWe are seeking a skilled Junior Attorney to join our growing Legal and Compliance department at Jane Street. As a key member of our transactional team, you will assist various business groups in drafting and negotiating complex agreements and advising on legal and regulatory matters.Key ResponsibilitiesNegotiate and draft a wide range of...
-
Legal Counsel
5 days ago
New York, New York, United States Jane Street Full timeAbout the PositionWe are seeking a skilled Transactional Lawyer to join our growing Legal and Compliance department at Jane Street. As a key member of our team, you will assist various business groups in drafting and negotiating complex trading and financing agreements, as well as advising on legal and regulatory matters.ResponsibilitiesNegotiate and draft a...
-
Director of Informed Consent Medical Writing
3 weeks ago
New York, New York, United States Merck Full timeJob DescriptionThe Medical Writing Department at Merck is seeking a highly skilled and experienced Director of Informed Consent Medical Writing to join our team. As a key member of our department, you will be responsible for the development and management of informed consent deliverables that support our clinical regulatory writing portfolio while ensuring...
-
Customs Documentation Specialist
1 month ago
New York, New York, United States Accelerated Global Solutions (AGS) Full timeCustoms Entry WriterWe are seeking a highly organized and detail-oriented Customs Entry Writer to join our team at Accelerated Global Solutions (AGS). In this role, you will be responsible for managing and preparing entry documents in compliance with U.S. Customs Service regulations and other relevant federal agency guidelines.Key...
-
Legal Counsel
5 days ago
New York, New York, United States Jane Street Full timeAbout the roleWe are seeking a junior Legal Counsel to join our growing Legal and Compliance department at Jane Street. You will assist various business groups in drafting and negotiating transactional agreements and advising on legal and regulatory matters.Key responsibilities of this role will include:Negotiating and drafting a broad range of complex...
-
Senior Manager
1 week ago
New York, New York, United States Citigroup, Inc. Full timeWealth Credit Management (WCM) at Citigroup, Inc. provides integrated end-to-end credit underwriting, transaction, and portfolio management in partnership with all the origination businesses of the Private Bank and Wealth Management.The Data Management team will be responsible for key aspects of data from definition to data capture, governance, and...
Nonclinical Regulatory Writer | DMPK
2 months ago
About Axelon Services Corporation
Axelon Services Corporation is a leading provider of scientific and regulatory support services to the pharmaceutical and biotechnology industries. We are committed to delivering high-quality, innovative solutions that help our clients bring life-saving therapies to market.
Nonclinical Regulatory Document and Scientific WriterWe are seeking a highly motivated and experienced Nonclinical Regulatory Document and Scientific Writer to join our growing team. In this role, you will play a critical part in the development and submission of regulatory documents for our clients' drug development programs.
Responsibilities:- Collaborate closely with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review, and track a wide range of regulatory documents. This includes but is not limited to INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans, and regular updates.
- Provide comprehensive quality review of DMPK reports generated by scientists, ensuring the validity and accuracy of reported data. Review and edit nonclinical study reports for regulatory acceptance, adhering to company templates, SOPs, DMPK/BA methods, work practices, and FDA GLPs as applicable.
- Assist in addressing Health Authority questions pertaining to DMPK and BA, working closely with SMEs and Regulatory representatives.
- Manage document timelines effectively, ensuring timely completion of authoring, review cycles, and submissions.
- Participate in department meetings to track and manage upcoming needs for nonclinical documentation.
- Demonstrate a deep understanding of the impact of DMPK/BA and its interdependencies with other functional teams within the organization, including Pharmacology, Toxicology, Clinical, and Regulatory disciplines.
- Bachelor's degree in Chemistry, Biology, or a related scientific field with a strong background in DMPK and BA, including knowledge of FDA GLPs.
- Minimum 5 years of experience in regulatory drug development.
- Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
- Comprehensive knowledge of DMPK/BA methods, data interpretation, and terminology.
- Strong analytical and problem-solving skills, with the ability to manage multiple projects and teams simultaneously.
- Exceptional project management and organizational skills to be flexible and adaptable to changing project priorities and work assignments.
- Excellent scientific writing, strong QC review skills, and verbal communication skills.
Axelon Services Corporation is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees feel valued and respected.
