Senior Regulatory and Start Up Specialist (Brazil)

We’re expanding our capabilities across  Mexico, Brazil, Argentina, Colombia, Chile, and Peru , and we’re hiring our first Senior Regulatory and Start Up Specialist (Senior RSS) in Brazil!

 

As the Senior RSS on our team, you are a seasoned, experienced professional in regulatory and site start-up activities. Responsibilities will be dependent upon the location of the Senior RSS and include but are not limited to initial and subsequent clinical trial submission to Competent Authorities and IRB/Ethics Committees, Informed Consent Form review and adaptation, Essential Document collection and quality review, supporting sites on IRB/EC submissions and providing support to the Site Contract Management group in budget and contract negotiation.

 

The Senior RSS may act as Subject Matter Expert for questions by other in-country members (CRAs, CSSs or others) supporting site start-up activities, trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents to increase knowledge share of country specific site start-up activities and 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 quality, of site activation readiness within the assigned country/sites and foreseeing and mitigating any risks

Preparation of Clinical Trial Application Forms as well as preparation of submission dossier (initial and amendments/notifications) for submission to Competent Authorities (CA) , Ethics Committee (EC) and other applicable local bodies according to local requirements and within required timelines to obtain all 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 Lead and/or Regulatory Lead 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 keep Regulatory Leadership updated

Preparation/Support the development of study specific start-up plans, IMP release requirements and essential document review criteria

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 Contracts management group on project specific status and deliverables

Act as SME for collection and maintenance of site level critical path to Site Activation data points, including but not limited to Competent Authority, local IRB/Ethics Committee (EC) timelines, site contracts and budget negotiation requirements for and other required reviews to secure on time site activation for the assigned sites in the country

When required, participate/support the negotiation of study budgets and the execution of investigator contracts under directions of Site Contract Management department/designee department

Keep an updated knowledge of the local clinical trial laws, regulations and help distributing this knowledge within Precision for Medicine to ensure the conduct of Clinical Trials according to international and local/national applicable regulations

Maintain audit/inspection readiness at all times and file documents as per TMF plan and/ or study specific plans in the relevant TMF

May support the clinical team performing Pre-Study Site Visits

May participate/support feasibility group in site outreach to assess potential interest of investigators to a potential study

May support development of country specific Country Start-up summary and process flow identifying timelines, risks, and success factors

May support development of training sessions to expand Country Start-up knowledge and act as Subject Matter Expert for queries

May mentor staff on local study start-up regulations, submissions, and internal procedures

May interact with clients to provide activation readiness status updates, request documents or document review, and participate in proposal activities, including slide development and client presentation as required

Performs other duties as assigned by management

 

Qualifications

 

Minimum Required:

Bachelors’ degree in life sciences or related field (ideally in a scientific or healthcare discipline), or Registered Nurse (RN) or equivalent combination of education, training, and experience

3.5 years or more as a Regulatory or SU specialist in either a CRO or pharmaceutical/ biotech industry or equivalent, relevant experience and/or demonstrated competencies

Ability to communicate both verbally and in writing at the English proficiently (Professional level)

 

Other Required:

Excellent communication and organizational skills are essential

Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail required

Fluency in English and for non-English speaking countries the local language of country where position based

Ability to prioritize workload to meet deadlines

 

Preferred:

Relevant regulatory and site start-up (feasibility, contract negotiations, CA/EC/IRB submissions) experience for the particular country

Experience using milestone tracking tools/systems

Can assist junior SU specialists in problem resolution

Advanced degree in medical or life sciences (MD, PhD, PharmD)/RAC certification/Masters in Regulatory Science

 

Competencies:

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Ability to follow task-specific procedures, be attentive to detail and place importance on accuracy of information

Excellent organizational skills

Ability to effectively interact 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 sense of urgency to match the pace

Must demonstrate excellent computer skills

Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade

Flexible attitude with respect to work assignments and new learning

Occasional travel may be required

 

#LI-AG2 #LI-REMOTE

 

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