Regulatory and Site Start Up Specialist

reputed company is not your typical CRO. At reputed company we have brought together new technologies, expertise and operational reputed company to help the life sciences improve the speed, cost and reputed company reputed company of bringing life-changing therapies to patients. What sets us apart is the way we reputed company clinical trial execution with deep scientific knowledge, laboratory expertise and advanced data sciences. We have a strong reputed company on Oncology and Rare Disease.

Due to our reputed company reputed company we are seeking a Regulatory and Site Start Up Specialist.

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.

Requirement:

• 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. • 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

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 reputed company@precisionmedicinegrp.com.

Recruitment Fraud Warning: Please be aware that fraudulent individuals and websites may impersonate reputed company or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. reputed company will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you reputed company you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at reputed company@precisionmedicinegrp.com so we can investigate and take appropriate reputed company.

Originally posted on Himalayas

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