Regulatory & Medical Affairs - Nonclinical Regulatory Document and Scientific Writer - Advent Global Solutions
Summit, NJ 07901
About the Job
Job Description: POSITION Nonclinical Regulatory Document and Scientific Writer
DEPARTMENT Nonclinical Safety and Veterinary Sciences (Company-VS)
PREREQUISITES
" Strong background in nonclinical Pharmacokinetics and experience with Global Health Authority interactions
" Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks
" Pharmaceutical/biotech industry experience of > 5 years
Responsibilities include:
1. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Including, but not limited to, INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans and regular updates of such documents. Regulatory submissions will span across all therapeutic areas (cancer, immunology, neurology etc.) and all modalities, including small molecule, large molecule, and cell therapies. Candidates will support multiple drug development programs. Drug development programs are global, so candidates will work on programs intended for US, EU, Japan and other world markets.
2. Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable. Ability to re-prioritize QC workloads quickly when needed, while meeting all necessary timelines.
3. Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.
4. Determine and manage document timelines through authoring, review cycles and on time completion.
5. Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.
6. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
7. Other duties related to the above within Client, as assigned.
Skills/Knowledge Required:
" At minimum, a Bachelor s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs.
" Regulatory drug development experience of > 5 years
" Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
" A strong knowledge of DMPK/BA methods, data interpretation and terminology is necessary.
" 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.
" Strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
" Careful attention to detail.
" Excellent scientific writing, strong QC review skills, and verbal communication skills required.
" Robust PC experience:
a. Training on in-house document repository system will be provided.
b. Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.
DEPARTMENT Nonclinical Safety and Veterinary Sciences (Company-VS)
PREREQUISITES
" Strong background in nonclinical Pharmacokinetics and experience with Global Health Authority interactions
" Experience reviewing regulatory documents, DMPK and BA reports, and non-GLP/GLP data and notebooks
" Pharmaceutical/biotech industry experience of > 5 years
Responsibilities include:
1. Partner with Drug Metabolism and Pharmacokinetic (DMPK) and Bioanalytical (BA) Subject Matter Experts (SMEs) to author, review and track regulatory documents. Including, but not limited to, INDs, CTAs, NDAs, BLAs, IBs, Pediatric Investigative Plans and regular updates of such documents. Regulatory submissions will span across all therapeutic areas (cancer, immunology, neurology etc.) and all modalities, including small molecule, large molecule, and cell therapies. Candidates will support multiple drug development programs. Drug development programs are global, so candidates will work on programs intended for US, EU, Japan and other world markets.
2. Assist with quality review of DMPK reports that are generated by DMPK scientists by fully reviewing the raw data outputs/electronic notebooks and ensuring validity and quality of reported data in the reports, in addition to reviewing DMPK regulatory documents, editing of nonclinical study reports for regulatory acceptance and adherence to company templates, SOPs, DMPK/BA methods, work practices and FDA GLPs, as applicable. Ability to re-prioritize QC workloads quickly when needed, while meeting all necessary timelines.
3. Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.
4. Determine and manage document timelines through authoring, review cycles and on time completion.
5. Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.
6. Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.
7. Other duties related to the above within Client, as assigned.
Skills/Knowledge Required:
" At minimum, a Bachelor s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs.
" Regulatory drug development experience of > 5 years
" Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
" A strong knowledge of DMPK/BA methods, data interpretation and terminology is necessary.
" 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.
" Strong interpersonal skills, be a team player, be able to self-advocate and willing to work in an environment where individual initiative and accountability are required.
" Careful attention to detail.
" Excellent scientific writing, strong QC review skills, and verbal communication skills required.
" Robust PC experience:
a. Training on in-house document repository system will be provided.
b. Microsoft Office Suite experience required including Microsoft Word, Excel, and Outlook.
Source : Advent Global Solutions
