Nonclinical Regulatory Document and Scientific Writer at HAYS in Trenton, New Jersey

Job Description:

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.


Applicants must be legally authorized to work in the United States. Sponsorship not available.


Our client is seeking a Nonclinical Regulatory Document and Scientific Writer in Summit, NJ.


Role Description


• 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.


Skills & Requirements


• 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.


Benefits/Other Compensation


This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).


Why Hays?


You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.


Nervous about an upcoming interview? Unsure how to write a new resume?


Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.


Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.


In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.


Drug testing may be required; please contact a recruiter for more information.


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#1163623 - Laurie McComb