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Company Name : Staffmark
Location : Township of Warren, NJ 07059
Position : Junior Regulatory Consultant
Job Description : Staffmark Professional Services is partnered with a client in search of a Jr Regulatory Consultant. This is a 12 to 13 month contract working 100% remote, and aligning with Pacific Time work hours! This position pays $45 to $50 per hr DOE, and offers access to medical dental and vision benefits after 30 days, with the option to contribute to a 401K starting day 1. We are looking for a dedicated, experienced professional to join this thriving team!
Crucial Job Duties and Responsibilities:
As a Junior Regulatory Consultant you will be supporting Regulatory Program Management Program Leads and other partners in preparing and facilitating meetings, teleconferences and other communications with regulatory authorities. As well as establishing effective working relationships internally and externally with those authorities.
You will also document meetings, teleconferences, communications and other interactions with all regulatory authorities. There will be additional regulatory and project-related support activities for this position on an as needed basis, as requested by the project leads & teams.
We are interested in finding someone who can support IND/NDA/BLA maintenance, filings (INDs, BLAs, NDAs), as well as FDA meetings, and post marketing activities. This position will also be responsible for representing the regulatory department at study team meetings, and answer regulatory questions.
What are we looking for?
2-5 years working experience, ideally in the healthcare or relevant industry.
Knowledge of Clinical regulatory role[s] in industry.
Should be fully proficient in teamwork/collaboration, achieving results, regulatory knowledge, operational excellence, Communication Skills, and organization.
Ideally some degree of direct therapeutic area experience.
Knowledge of GxP, ICH, and other regulatory guidelines.
Knowledge of the drug development process and how other functions add to this process.
Strong project management, leadership skills.
Good verbal and writing skills; proficient in MS Office apps
EXAMPLES OF WORK (illustrative of the types of projects that this position has worked on previously, not necessarily a definitive list of what the future workload will be comprised of):
Acting as the project coordinator for various regulatory strategy initiatives that are focused on improving performance, reducing complexity and differentiating regulatory.
Extracted themes about relevant business trends from benchmarking reports and assess the company’s readiness to continue being a driven and innovative company in the future
Capturing insights from leaders in R&D, Business Development, Product and Portfolio Planning and Finance Forecasting space
Providing regulatory support for 20+ Phase I and Phase III Oncology studies
Supporting global regulatory strategy development, project management, and cross-functional partner management for various drug development programs
Assisting in authoring various regulatory documents and coordinating their submission to FDA
Managing responses to information requests from FDA, which included crafting and maintaining timelines for authoring, review and adjudication as well as driving the response document from time of receipt to time of submission
Supporting cross-functional teams in preparation for FDA meetings
Assembling Module 1 for a marketing application for a small molecule currently in development for prostate and breast cancer indications
About Staffmark
Staffmark is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Staffmark is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.
All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.
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