*Hi,*
Hope you are doing well ! My name is *Steven* and I am a Recruiter with *Infotree Services*. With reference to your resume registered at *Monster.com*. I have an urgent opening with me, which appears to be a potential match for the client's requirement. I have listed the job description for your reference. Please let me know if you would be interested in this position. If so, please send me a copy of your updated resume with contact details and the best time to reach you. I will appreciate your response at the earliest, as the manager tends to move fast ! *Job Details** :* *Job Title* *Clinical Trials Disclosure Associate* *Project Location* *Woodcliff Lake, NJ 07677* *Duration* *12+ months/Contract (Potential to extend)* *Job Description** :* *Clinical Trials Disclosure Associate * The Clinical Disclosure Associate will work across multiple disciplines within and outside Regulatory Affairs to drive departmental and project objectives. Person will be responsible for coordinating the posting of registration and disclosures on clinicaltrials.gov, EudraCT and other registries for company-wide studies. This comprises supervision of the vendor as well as coordination of company internal processes to ensure compliance with all relevant legal obligations (primarily clinicaltrials.gov and EudraCT disclosure). Must be database proficient with registrations and disclosures. Has the ability to work cross-functionally and meet required deadlines. Ensures trial disclosure is in compliance with applicable regulations globally. Develops and maintains strong internal relationships across all levels of the clinical organization. Escalates issues to management in an expedient manner. Continually train and remain in compliance with all current industry requirements as they relate to clinical trial disclosures. On occasion, responsibilities may be extended to: - reviews of clinical and regulatory documents and regulatory submissions for data accuracy, consistency, formal quality and readability, resolving identified issues in collaboration with authors in a productive fashion Coordinates all Eisai clinical disclosure activities, acting as primary intermediary between the disclosure vendor and Eisai contacts 30 Works with Eisai contacts to identify and resolve compliance gaps 30 Supports continual improvements by evaluating disclosure business process, suggests and implements improvements to enhance compliance, documents processes and trains relevant personnel 20 Maintains Eisai disclosure trackers and produces metrics reports for management 10 Maintains Eisai product information for use in disclosure activities 10 *Bachelor’s degree required* At least 3 years working in the p*harmaceutical industry in an R&D *environment. Solid knowledge of clinical trial transparency principles, preferably on an international level Strong attention to detail and the ability to work as a part of a team across multiple departments Strong communication and influencing skills *Thanks & Regards,* *Steven* - Technical Recruiter *Phone *(Direct): 734-888-8174 *Email:* [email protected] <[email protected]> | *Website:* www.infotreeservice.com *LinkedIn:* https://www.linkedin.com/pub/steven-fernandez/104/956/240 *Hangout:* steven.usrecruiter | *Yahoo:* steven.usrecruiter *Mailing Address:* 215 Ann Arbor Rd. Suite 304 Plymouth, MI 48170 [image: Description: Description: Description: cid:[email protected]] ------------------------------ “This message and any attachments are solely for the intended recipient and may contain confidential or privileged information. If you are not the intended recipient, any disclosure, copying, use, or distribution of the information included in this message and any attachments is prohibited. If you have received this communication in error, please notify us by reply e-mail and immediately and permanently delete this message and any attachments. Thank you.” -- You received this message because you are subscribed to the Google Groups "it req" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/it-req. For more options, visit https://groups.google.com/d/optout.
