Regulatory Documentation Analyst Pharma (Hybrid New Brunswick, NJ)
We are seeking a Documentation Analyst for a global pharmaceutical client. This position involves compiling information from scientists, authoring the chemistry, manufacturing, and controls (CMC) sections of regulatory documents, and performing data integrity checks to support the timely submissions of both investigational and marketing applications for small and large molecules.
This is a 40-hour per week, 6-month contract (extensions possible), 50% onsite role in New Brunswick, NJ.
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities:
Involves compiling information from scientists, authoring the chemistry, manufacturing, and controls (CMC) sections of regulatory documents, and performing data integrity checks to support the timely submissions of both investigational and marketing applications for small and large molecules.
Constructive interactions with other members of a team to approach problem-solving
Requirements:
4+ years of experience in Regulatory Documentation and/or Authoring experience (not just formatting) in the Pharma industry
Requires knowledge of fundamental principles of organic chemistry, the critical evaluation of analytical data, and it is preferred to have experience in drug substance and/or drug product CMC development. Strong organic or Medicinal chemistry
Familiarity with computer-assisted document preparation tools is desirable.
B.S. in Chemistry is required. An M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred
Please submit your resume to our network at (please apply to the Regulatory Documentation Analyst Pharma (Hybrid New Brunswick, NJ) role.
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates' qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $38/hr. - $41.81/hr.
#LI-SW1
...collaboration are among our core principles. Work with a dedicated and caring organization and start doing your life's best work. Mental Health Assistant (1099) Pay rate: $20.00 per hour (1099). Address : Department of Health and Human Services 36 Clinton Street, Concord...
...Job Description As composite mechanic you will be working on Boeing 787 and Airbus... ...manuals, component maintenance manuals and aircraft maintenance manuals, as well as other... ...station. Qualifications ~ AOG experience 5 years~"Composite Repair" vs "Composite...
...We have an amazing opportunity for massage therapists, who want to help promote health, wellness, and empower self love. Our position comes with benefits, insurance, growth opportunities, flexible scheduling, and continuing training. Take the next step in your career...
...consistently ranked as a top workplace among DC area firms and continues to grow. We are actively hiring a Senior Level Spanish Linguist to join our team working in Reston, VA. You will be responsible for supporting a government agency and your office with...
...Rig Hand Beckman Production is an oilfield well-servicing and trucking company. We are looking for rig hands to help operate the service... ..., anchor setting trucks, wireline units, vacuum trucks, crude oil trucks and tankers licensed to haul non-hazardous liquid waste and...