Ssu & Regulatory Specialist Sr or Ii Brazil

**Description**

**Site Start-Up & Regulatory Specialist Sr or II Brazil**

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason - we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

**Why Syneos Health**
- #SyneosHealthLife means we’re committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
- We believe our success is a direct result of the people who are driving it - you We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- General - Responsible for quality deliverables at the country level; follows project requirements and applicable country rules, with mínimal oversight from the SSU Country Manager. Forecasts submission/approval timelines, ensures compliance and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached analyses data to provide clear rationale for delays, provides contingency plans to mitigate impact, and escalates the issue as soon as identified. Monitors financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion. Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WI) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance. Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements. Ensures continuous improvement of quality in all Site Start-Up (SSU) components at the country level where assigned (submissions, essential document collection, communication to Competent Authorities and ECs, etc.). May be involved in vendor management.

Responsible for one or more of the following functions at the country level:

- Local Submissions Specialist - Follows the project direction and expertise provided by the designated country start-up advisor (CSA) and PM/SSUL. May serve as the primary point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site. Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
- Oversees ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with mínimal oversight from the SSU Country Manager.
- Country Start-Up Advisor - Acts as Subject Matter Expert for in-country performance within the Site Start-Up. Acts as country-level intelligence on start-up (SU) and clinical trial regulatory (CTR).
- Local Site ID and Feasibility Support - Provides support site selection lead and PM/SSUL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
- Local Investigator Contract and Budget Negotiator - Produces site-specific contracts from country clinical trial agreement (CTA) template. Reviews and owns site-specific contracts from country template. Submits proposed CTA and investigator budget for site review. Negotiates budget and contract with site and via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
- Line management / mentoring responsibilities - As part of developmental plans, it may be requested to provide support to management in activities such as interviewing and selection, professional development, performance management, and employee counseling and separations. Advises junior team members on administrative policies and procedures, technical problems, priorities and methods.
- Ensure all relevant documents are submitted to