Promotional Review Committee Specialist

Kyowa Kirin Bedminster , NJ 07921

Posted 2 months ago

JOB DESCRIPTION:

The Promotional Review Committee (PRC) and Medical Review Committee (MRC) Coordinator will be responsible for coordinating all marketing and medical material for specified brands and routing this material through an approval process.

ESSENTIAL DUTIES & RESPONSIBILITIES:

  • Coordinate the development and distribution of PRC/MRC agendas

  • Submit all materials being reviewed into electronic routing system (veeva)

  • Coordinate and facilitate the PRC/MRC meeting flow as it relates to the distributed agenda

  • Accurately document any requested changes and/or edits to promotional materials by the PRC/MRC and distribute to the originators for verification

  • Work with the relevant brand and/or functional team and agency of record (AOR) to ensure changes requested by the PRC/MRC are completed

  • Oversee, track and ensure annual re-review of all promotional material

  • Develop and maintain an up-to-date core reference binder new and promoted brands

REQUIREMENTS:

  • Bachelor's degree or equivalent work experience

  • Minimum 2 years of related advertising/marketing experience in the pharmaceutical industry is preferred

  • Knowledge of general office practices, procedures and equipment

  • Proven track record of managing multiple projects simultaneously

  • Excellent keyboard skills, with experience using Microsoft Office

  • Skilled in real time editing of documents and materials within Adobe Acrobat

  • Experience with electronic document control/management system

  • Exceptional communication, problem solving, attention to detail

  • Strong interpersonal, teamwork, organizational and workload planning skills

  • Ability to act independently and take initiative

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon
lc_ad

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Manager PV Operations/Senior PV Operations Specialist

Kyowa Kirin

Posted 7 days ago

VIEW JOBS 5/20/2020 12:00:00 AM 2020-08-18T00:00 • Proactively providing case processing activities as requested to ensure high-quality individual case safety reports of adverse events reported following the use of Kyowa Kirin's products promptly. * Provides accurate individual case reports for submission to regulatory authorities, partner companies and participating clinical trial investigators in compliance with the regulatory timeframes for reporting. * Participate in regular meetings with internal and external stakeholders including case processing vendors for effective issue resolution. * Maintain oversight of vendor activities including routine review of cases, reconciliation and monthly review meetings. * Serves as a member of project teams. Communicates timelines, delivering quality and timely input to meet the needs of the project team and informs the project team on the status of activities and issues. * Maintain awareness of changes to regulatory guidance documents, requirements and state-or-the-art pharmacovigilance processes and make recommendations leading to operationalize and improve the effectiveness and profile of the department. * Revises and maintains processes and procedures for drug safety in compliance with regulatory requirements and company standards. * Provide training to case processing vendor. * Review, revise and approve Change Controls, Safety Management Plans, PV Agreements, SOPs, Working Instructions and other guidance documents, as needed, concerning the Global Case Management. * Support Pharmacovigilance Audits and Inspections as needed concerning the Global Case Management function. * Any other activity that may reasonably be required. Education and experience Healthcare professional or life sciences degree preferred. Previous experience working within a Pharmacovigilance Department desirable. Technical Skills Strong knowledge of pharmaceutical/biotech industry and the overall drug development process * Knowledge of relevant FDA, EU, PMDA, Health Canada and ICH guidelines, initiatives and regulations governing both clinical trial and post-marketing safety environments * Expertise in MedDRA and WHO-DO coding dictionary * Knowledge of computerized Safety data entry and MedDRA. * Experience in managing vendors, alliance partners and CROs is a plus. * Very good written and oral communication skills * Demonstrated ability to learn new software applications * Expert computer skills (MS Office) Non-Technical Skills Cultural sensitivity is essential and the ability to develop consensus within a multinational organization necessary. Broad level of interpersonal skills and flexibility also necessary. Responsible, flexible and accountable with a pro-active approach and able to work to deadlines. Ability to plan and prioritise multitask / multiproject workload Kyowa Kirin Bedminster NJ

Promotional Review Committee Specialist

Kyowa Kirin