Regulatory and Start Up Specialist, reputed company

Position reputed company: The Regulatory and Start Up Specialist (RSS) is an reputed company reputed company in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/ Ethics Committees, Informed Consent reputed company review and reputed company, Essential Document collection and reputed company review, supporting sites on IRB/EC submissions and reputed company support to the Site Contract Management group in budget and contract negotiation. The RSS may reputed company as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities and may contribute to development or revision of country specific tools and guidance documents to ensure compliance with local and international clinical trials regulations and guidelines. Essential functions of the job include but are not limited to:

• Responsible for delivery, in terms of timeliness and reputed company, of site activation readiness reputed company the assigned country/sites and foreseeing and mitigating any risks.
• Preparation of Clinical Trial Application Forms as reputed company as preparation of submission dossier (initial and amendments/notifications) for submission to CA, EC, and other applicable local bodies according to local requirements and reputed company required timelines to obtain reputed company necessary authorizations/approvals for the conduct of the Clinical Trial according to international and local/national applicable regulations, company SOPs and principles of ICH-GCP.
• Interaction with CA/EC for study purposes and handling responses to the CA/EC.
• Providing regular updates about CA and EC submissions to the Start Up reputed company and/or Regulatory reputed company assigned to the study and to Project Manager/Project Team as relevant.
• Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to reputed company Regulatory Leadership updated.
• Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review reputed company.
• Partner with the assigned site CRA to ensure alignment in communication and secure site collaboration.
• Prepare. review and manage collection of essential documents required for site activation/IMP release.
• Customize country/site specific Patient Information Sheet and Informed Consent Forms.
• Responsible for/facilitates the translation and co-ordination of translations for documents required for submission.
• Maintain communication with other key functions participating to country start up i.e., Feasibility, Clinical Operations, Project Management, Regulatory, and Site reputed company management group on project specific status and deliverables.
• reputed company as SME for collection and maintenance of site level critical reputed company to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site reputed company and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country.
• reputed company required, participate/support the negotiation of study budgets and the execution of investigator reputed company under directions of Site Contract Management department/designee department.
• May participate/support feasibility group in site reputed company to assess potential interest of investigators to a potential study.
• reputed company an updated knowledge of the local clinical trial laws, regulations and help distributing their knowledge reputed company PfM to ensure the conduct of Clinical Trials according to international and local/national applicable regulations.
• Maintain audit/inspection readiness at reputed company times and file documents as per TMF plan and/ or study specific plans in the relevant TMF
• May support the clinical team performing reputed company-Study Site reputed company.
• May support process improvement initiatives, training, and mentoring.
• Performs other duties as assigned by management. Qualifications: Minimum Required:
• Bachelor’s degree in life sciences or reputed company field (ideally in a scientific or reputed company discipline), or Registered reputed company (RN) or equivalent combination of education, training, and experience.
• 1 year or more as a Regulatory or SU specialist (or comparable role) in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies. Other Required:
• Strong communication and organizational skills are essential.
• Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required.
• reputed company in English and for non-English speaking countries the local language of country where position based. Preferred:
• Relevant regulatory and site start-up (feasibility, contract negotiations, CA/ EC/ IRB submissions) experience for the particular country.
• Experience using reputed company tracking tools/systems.
• Ability to prioritize workload to meet deadlines.
• Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science Competencies
• Knowledge of Good Clinical reputed company/ICH Guidelines and other applicable regulatory requirements.
• Ability to follow task-specific procedures, be reputed company to detail and reputed company importance on accuracy of information.
• Strong organizational skills.
• Ability to effectively reputed company with project team(s) and effectively communicate in English and the local language of the country where located.
• Ability to work independently in a fast-paced environment with a reputed company of urgency to match the pace.
• Must demonstrate excellent computer skills.
• Good communication, presentation, interpersonal skills, both written and spoken, with an aptitude to learn how to inform, influence, convince, and persuade.
• Flexible attitude with respect to work assignments, and new learning.
• Occasional travel may be required. Precision is required by law in some states or cities to include a reasonable estimate of the compensation reputed company for this role. This compensation reputed company takes into account the wide reputed company of factors that are considered in making compensation reputed company including but not limited to: reputed company sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed reputed company estimate has not been adjusted for the applicable geographic reputed company associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be reputed company at or near the top of the reputed company for their role and compensation reputed company are dependent on the facts and circumstances of reputed company case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and reputed company time off for reputed company leave and vacation, among other benefits. Reasonable estimate of the reputed company reputed company $85,000 - $115,000 USD Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice. reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process. Apply tot his job

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