Theradex Oncology

About Theradex Oncology

About Us: Theradex Oncology is a leading global oncology CRO in business for over 35 years. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. Our company has a newly created position for a Regulatory Publishing Associate to work onsite in our Princeton, NJ headquarters. This role supports regulatory affairs and document management as well as our medical writing team. What you need: Bachelor’s degree required Minimum 1-2 years of publishing experience in a CRO or Pharmaceutical setting Excellent working knowledge of Microsoft Office software, especially Microsoft Word High-level proficiency in creating, editing, formatting and optimizing portable document format (PDF) files and properties; experience with Adobe Pro Strong writing, communication and problem-solving skills Well organized with good attention to detail Experience working in an SOP-driven environment Knowledge of CTD Standards and ICH preferred Familiarity with xml structures of metadata preferred What you’ll do: Complete FDA (and EU) submissions according to regulatory deadlines. Compilation of submission documentation, (including uploading/formatting and QC of relevant documents) Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements. Ensure document formatting for paper and electronic documents are correct and appropriate and according to standards. Maintain publishing and quality control logs. Support medical writing team with publishing on all IND eCTD submissions in the US. Provide regulatory publishing support to other departments as needed. Other activities as may be assigned by management. Compilation of submission documentation, (including uploading/formatting and QC of relevant documents) Complete FDA (and EU) submissions according to regulatory deadlines. Maintain basic knowledge of current electronic publishing standards, regulatory guidelines, and legal requirements. Ensure document formatting for paper and electronic documents are correct and appropriate and according to standards. Maintain publishing and quality control logs. Support medical writing team with publishing on all IND eCTD submissions in the US. Provide regulatory publishing support to other departments as needed. Other activities as may be assigned by management. Other Responsibilities, as required: Perform formatting and content quality control review of regulatory and clinical study documents according to department guidelines. Work with functional teams to collect, file, and track documentation for electronic document management system (Veeva). Assist in the develop of clinical documentation such as informed consent forms or templates, work instructions, or checklists What we offer: We offer a supportive culture that puts people first. We provide a competitive compensation and benefits package including medical, dental, vision, life insurance, STD/LTD, 401(k), tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more. Sponsorship or relocation is not offered for this position. Theradex is an Equal Opportunity Employer. Search Firm Representatives: Theradex is not accepting assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Theradex via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Theradex. No fee will be paid in the event the candidate is hired by Theradex as a result of the referral or through other means.

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Company Info

Company Type: Private

Company Size: 51 - 250

Revenue: 5 - 25 million (USD)

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