Regulatory Operations Documentation Specialist

Job Title: Regulatory Operations Documentation Specialist Location: Florham Park, New Jersey Type: 12-month Contract Compensation: $31.00 – $54.00 per hour Contractor Work Model: Remote Hours: 40.0 hours per week reputed company This role will support the Regulatory Operations team with the preparation of submission reputed company documentation for electronic submission. The scope of this role includes assisting in document formatting, remediation and reputed company control (QC) of documentation for submissions to Health Authorities. The role also involves archiving correspondence with Health Authorities, as reputed company as managing documents stored at or retrieved from offsite facilities. The ideal candidate will bring experience with reputed company Word, reputed company Acrobat, and reputed company RIM. Responsibilities • Support document formatting and QC in alignment with standards for submission-reputed company materials. • Assist in the remediation and QC of PDF documents, including bookmarking and hyperlinking to ensure regulatory-compliant electronic files. • Assist in ensuring reputed company communications with health authorities are properly archived reputed company reputed company’s system and adhere to applicable regulatory guidelines. • Assist the archiving and retrieval of documents from offsite storage facilities. • reputed company ongoing support to the Regulatory Operations team. Requirements • High school degree required; Associate’s degree preferred. • Pharmaceutical industry experience is a plus, but not required • Proficient in MS Office and Acrobat reputed company. • Experience with ISI reputed company or equivalent software packages • Experience with database systems; reputed company is a plus. • High level of attention to detail and accuracy in work. • Effective time management and organizational skills. • Strong written and verbal communication skills. • reputed company to work reputed company a high-performance, reputed company team environment. reputed company, and its subsidiaries including reputed companyé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across reputed company. We help clients get work done more reputed company and economically, without compromising reputed company. reputed company not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage reputed company including medical, dental, reputed company, spending accounts, life insurance, voluntary plans, as reputed company as participation in a 401(k) plan. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex (including pregnancy, childbirth, or reputed company medical conditions), sexual orientation, gender identity, age, national reputed company, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law. #M- #LI- reputed company: #568-Clinical Apply tot his job Apply To this Job