Innova Solutions Inc.
Nonclinical Regulatory Document and Scientific Writer - Technical Writer
Innova Solutions Inc., Lakewood, New Jersey, us, 08701
Nonclinical Regulatory Document and Scientific Writer - Technical Writer
Job ID: 979108 Summit, New Jersey Job Type: Contract Added - 07/26/24Job Description
Innova Solutions is immediately hiring for a Nonclinical Regulatory Document and Scientific Writer
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.Position Type: ContractDuration- 12 MonthsLocation- New Brunswick, NJ
As
a Regulatory Document and Scientific Writer,
you will: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.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.Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.Determine and manage document timelines through authoring, review cycles and on time completion.Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.Other duties related to the above within Organization, as assigned.
The ideal candidate would possess:
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 yearsExperience with CTD documents and nonclinical study reports for submission to global regulatory agencies.A strong knowledge of DMPK/BA methods, data interpretation and terminology are 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.Excellent scientific writing, strong QC review skills, and verbal communication skills required.
PAY RANGE AND BENEFITS:Pay Range*: $ 55 -$ 58 per hour.*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits:
Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
Innova Solutions
is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.#J-18808-Ljbffr
Job ID: 979108 Summit, New Jersey Job Type: Contract Added - 07/26/24Job Description
Innova Solutions is immediately hiring for a Nonclinical Regulatory Document and Scientific Writer
Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.Position Type: ContractDuration- 12 MonthsLocation- New Brunswick, NJ
As
a Regulatory Document and Scientific Writer,
you will: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.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.Assist in addressing Health Authority questions pertaining to DMPK and BA with the SMEs and Regulatory representatives.Determine and manage document timelines through authoring, review cycles and on time completion.Attend department group meetings for tracking and management of upcoming needs for nonclinical documentation.Understand the impact of DMPK/BA and interdependencies with other functional teams within the enterprise including Pharmacology, Toxicology, Clinical and Regulatory disciplines.Other duties related to the above within Organization, as assigned.
The ideal candidate would possess:
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 yearsExperience with CTD documents and nonclinical study reports for submission to global regulatory agencies.A strong knowledge of DMPK/BA methods, data interpretation and terminology are 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.Excellent scientific writing, strong QC review skills, and verbal communication skills required.
PAY RANGE AND BENEFITS:Pay Range*: $ 55 -$ 58 per hour.*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits:
Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
Innova Solutions
is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates.#J-18808-Ljbffr