Ssu & Regulatory Specialist I-ii

hace 1 semana

Edo de México Syneos Health Clinical A tiempo completo

**Description**

**Site Start-Up & Regulatory Specialist II**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- 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**
- Responsible for the quality deliverables at the country level; follows project requirements and applicable country rules, with moderate oversight from the SSU Country Manager.
- Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached: investigates and provides clear rationale for delays, provides support on contingency plan to mitigate impact, and escalates the issue as soon as identified.
- Monitors basic 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.
- Supports 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.).
- Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

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

- Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SSUL. May serve as a point of contact for the PM/SSUL (or designee) during start-up on allocated projects. Complies 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.
- Prepares 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 moderate oversight from the SSU Country Manager.
- Local Site ID and Feasibility Support - Provides support with 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 - Provides support to SSUL to agree on country template contract and budget. Produces site-specific contracts from country template. Provide support in submissions for proposed contract and budget for site. Provides support in negotiating budget and contract with site via Site Contracts Service Centre and SSUL with Sponsor until resolution of issues and contract execution. Performs quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

**Qualifications**

**What we’re looking for**
- Bachelor’s Degree,
- Detailed understanding of clinical trial process across Phases II-IV and ICH GCP.
- Ability to understand clinical protocols and associated study specifications.
- Deta

  • Ssu & Regulatory Specialist I Client Based Mexico

    hace 1 semana

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Site Start-Up & Regulatory Specialist I** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer...

  • Ssu & Regulatory Specialist I Mexico Client Based

    hace 1 semana

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Site Start-Up & Regulatory Specialist I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value...

  • Regulatory Specialist Ii

    hace 1 mes

    Ciudad de México Givaudan A tiempo completo

    Join us and celebrate the beauty of human experience. Create for happier, healthier lives, with love for nature. Together, with kindness and humility, we deliver food innovations, craft inspired fragrances and develop beauty and wellbeing solutions that make people look and feel good. There’s much to learn and many to learn from, with more than 16,000...

  • Regulatory Specialist Ii

    hace 2 meses

    México Sensient Technologies A tiempo completo

    As a valued member of our Sensient global Regulatory team, in this role as a Regulatory Specialist you assure the compliance of our products with appropriate regulations, provide various data, information and conformity declaration, and you serve as a regulatory resource to internal and external customers. You maintain technical databases related to raw...

  • Site Activation Manager Ii

    hace 5 días

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Site Activation Manager II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our...

  • Sr Site Contracts Specialist

    hace 1 semana

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **JOB TITLE: Senior Site Contracts Specialist** **SELECT ONE: Clinical Solutions** **JOB CODE**:SH2317** **JOB FAMILY: Clinical Operations** *** **BUSINESS UNIT** **(COMMERCIAL ONLY)**: **REPORTS TO**:Manager, SSU & Regulatory; or designee** **JOB SUMMARY**: **JOB RESPONSIBILITIES**: - May lead multi-country projects including...

  • Regulatory Specialist Latam

    hace 2 meses

    Ciudad de México Red Bull Gruppe A tiempo completo

    The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering technical and legal...

  • Specialist, Country Study Start Up

    hace 2 semanas

    Ciudad de México ABBVIE A tiempo completo

    **Purpose**:The Specialist, Country SSU proactively drives and executes all start up and maintenance related activities and deliverables for assigned studies and sites in their assigned country or countries. - Note: Specialists will report into their local country COM but have an operational reporting line to Area and Global SSU Leads_ **Primary...

  • Regulatory Specialist

    hace 2 semanas

    Ciudad de México HAYS A tiempo completo

    CDMX Permanent offer Hybrid **Your new company** Leading company in the development and manufacture of consumables for the Printing Industry, is looking for its Regulatory Compliance Specialist. **Your new role** *** You will be responsible of: - Maintain regulatory records, manage and update regulatory system data in various databases. - Prepare data...

  • Regulatory Specialist Latam

    hace 1 mes

    Ciudad de México Red Bull A tiempo completo

    **Company Description**: The legal team protects Red Bull, its people, partners and vendors by adding value to each product line and initiative. Legal is divided into Legal Business Partners for the Beverage Business and Corporate Projects, Specialist Departments and Centers of Expertise. The Regulatory Specialist assists the LATAM Regional team by offering...

  • Regulatory Affairs Specialist

    hace 2 meses

    México Groupe ProductLife A tiempo completo

    In the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM. Responsibilities Provide guidance and support about Mexican and Central America legislation Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...

  • Ssu Cra

    hace 5 días

    Ciudad de México Novartis A tiempo completo

    Site relationship management role to ensure sustainable trial start-up at Site. The Study Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV GDD trials within the country in adherence with monitoring procedures and processes in accordance with ICH/GCP, local...

  • Sr Clinical Operations Specialist with Regulatory

    hace 3 semanas

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **SSU & Regulatory Specialist with experience in clinical trials-Client Based Mexico (CDMX)** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market...

  • Regulatory Affairs Specialist

    hace 2 meses

    Ciudad de México Edwards Lifesciences A tiempo completo

    Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to...

  • Safety & Pv Specialist I

    hace 5 días

    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Safety & Pharmacovigilance Specialist I** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value...

  • Trial Activation Approval Specialist I

    hace 1 mes

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    **Job Description**: Trial Activation Approval Specialist I - Essential Functions and Other Job Information: - Essential - Functions- Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy.- Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with...

  • Trial Activation Approval Specialist I

    hace 1 mes

    Ciudad de México Thermo Fisher Scientific A tiempo completo

    **Job Description**: Trial Activation Approval Specialist I Essential Functions and Other Job Information: Essential Functions - Prepares, reviews and coordinates, under guidance and local EC submissions in alignment with global submission strategy. - Supports preparation, under guidance, of local MoH submissions, as applicable in alignment with global...

  • Senior Specialist, Regulatory Affairs

    hace 2 semanas

    Ciudad de México Mastercard A tiempo completo

    Our Purpose We work to connect and power an inclusive, digital economy that benefits everyone, everywhere by making transactions safe, simple, smart and accessible. Using secure data and networks, partnerships and passion, our innovations and solutions help individuals, financial institutions, governments and businesses realize their greatest potential. Our...

  • Infra Fin IT Specialist Ii

    hace 2 meses

    México Santander A tiempo completo

    INFRA FIN IT SPECIALIST II Country: Mexico **WHAT YOU WILL BE DOING** Principales actividades: 1. Establecer metas del área técnica con enfoque a resultados. 2. Planear y dar seguimiento a las iniciativas definidas por la dirección del área. 3. Facilitación de procesos y motivación del equipo. 4. Apego del área a principios, ética y desempeño...

  • Infra Ciso IT Specialist Ii

    hace 4 días

    México Santander A tiempo completo

    INFRA CISO IT SPECIALIST II Country: Mexico **WHAT YOU WILL BE DOING** Principales actividades: 1. Establecer metas del área técnica con enfoque a resultados. 2. Planear y dar seguimiento a las iniciativas definidas por la dirección del área. 3. Facilitación de procesos y motivación del equipo. 4. Apego del área a principios, ética y desempeño...