14 publicaciones de empleo destacadas en regulatory affairs (¡Están contratando!)

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Local Study Associate Director - FSP
Parexel —Ciudad de México, CDMX
- Administración de personal
- Inglés
- Licenciatura
Country Approval Specialist / Sr Country Approval Specialist
Thermo Fisher Scientific —Desde casa
- Tiempo completo
- Home Office (Desde casa)
- Administración de personal
- Inglés
- Microsoft Office
Sr Product Manager - Biosimilars
Abbott Laboratories —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Mercadotecnia
- Inglés
5d
Head of Trade LATAM & Pharma Mexico
Sanofi —Ciudad de México, CDMX
- Administración de personal
- Experiencia en ventas
- Hospital
Site Activation Specialist - Futures Roles (Mexico)
サイネオス・ヘルス —Tlalnepantla, Méx.
- Hospital
- Contratos
Customs Analyst
Diageo —Ciudad de México, CDMX
- Tiempo completo
- Microsoft Excel
- ERP systems
- Análisis de datos
2d
Product Manager (Mexico City)
BeiGene —City, Hgo.
- Tiempo completo
- Administración de personal
- Doctorado
- Experiencia en ventas
Medical Director (Endocrinology)
ICON Plc —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Disponible para viajar
- Seguro dental
- Seguro de la vista
Sr Associate - Consumer Digital Ecosystem
Eli Lilly —Ciudad de México, CDMX
- Tiempo completo
- Administración de personal
- Inglés
- Disponible para viajar
8d
Office Manager
FENIXFARMA —Colonia Polanco, CDMX
- $15,000 a $22,000 por mes
- Tiempo completo
- Español
- Microsoft Excel
- Mantenimiento
Postulación rápida
12d
Senior Clinical Data Engineer (LATAM)
Precision Medicine Group —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Technical Services Analyst
Kemin —Zapopan, Jal.
- Tiempo completo
- Ingeniería
- Inglés
- Licenciatura
Diseñador Gráfico Freelance
Innova Talent - Soluciones Humanas —Zapopan, Jal.
- $500 por día
- Por temporada
- Licenciatura
- Trabajo desde casa
Postulación rápida
Senior Clinical Data Engineer (LATAM)
Precision for Medicine —Desde casa
- Home Office (Desde casa)
- Administración de personal
- Inglés
- SQL
Postulación rápida

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Analista de Microbiología
Neolpharma —Coyoacán, CDMX
Disponibilidad para rolar 3 turnos (Se realiza el cambio cada 15 días). QFI, QFB, IF, IBT, Ingeniero Químico o afín, Titulado con Cédula.
Postulación rápida
Formulador
Pronaquim —Coyoacán, CDMX
Conocimiento de las normas COFEPRIS 251 (suplementos) o 259 cosméticos. Desarrollo de formulaciones de acuerdo con las necesidades de producción.
$16,000 por hora
Postulación rápida
7d

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Local Study Associate Director - FSP

Parexel -
Ciudad de México, CDMX

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Información del empleo

Cualificaciones

Administración de personal
Inglés
Licenciatura
Estimación y pronóstico
Habilidades de organización
Habilidades de comunicación
Negociación

Descripción completa del empleo

The Local Study Associate Director (LSAD) leads Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with Client Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.

The LSAD may perform site monitoring as needed to support the flexible capacity model.

The LSAD is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Trial and Site Administration

Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with client Procedural Documents, ICH-GCP and local regulations.
Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
Plans and coordinates applicable to local drug activities (from local purchase or reimbursement to drug destruction).
Sets up and maintains the study in CTMS at study country level and local websites as required by local laws and regulations.
Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
Reviews monitoring visit reports (as required and following Client SOPs) and pro-actively advises the monitor(s) on study related matters.
Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
Proactively identifies risks and facilitates resolution of complex study problems and issues.
Organizes regular Local Study Team meetings on an agenda driven basis.
Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders.
Reports study progress/update to the Global Study Associate Director/ Global Study Team including Site Management and Monitoring (SMM) Lead.
Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary.
Develops, maintains and reviews risk management plans on country study level; proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed.
Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable.
Plans and leads National Investigator meetings, in line with local codes, as required.
Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies.
Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and client Procedural Documents.
Plans and leads activities associated with audits and regulatory inspections in liaison with Clinical Quality Associate Director (CQAD) and QA.
Provides input to process development and improvement.
Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues.
Updates Line Managers about the performance of the CRAs/CSAs.
Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market.
Collaborates with local Medical Affairs team.
Supports SMM in different initiatives (local, regional or global) as agreed with the SMM Line Management

Document Management

Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant client SOPs and local regulations.
Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with Client SOPs.
Ensures completeness of the eTMF and ensures essential documents are uploaded in a timely manner to maintain the eTMF “Inspection Ready”.
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.

Regulatory and Site Start Up Responsibilities

Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organized at country level.

Budgeting, Agreements and Payments

Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in client clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head).
Ensures timely preparation of local Master Clinical Study Agreement (CSA) (including site budget) and amendments as needed.
Ensures accurate payments related to the study are performed according to local regulations and agreements.

Skills (Essential):

Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
Excellent project management skills.
Excellent team building and interpersonal skills.
Excellent organizational skills.
Excellent verbal and written communication skills.
Excellent ability to prioritize and handle multiple tasks.
Excellent attention to detail.
Proficient in written and spoken English language required.
Fluency in local language(s) required.
Good negotiation skills.
Good ability to learn and to adapt to work with IT systems.

Knowledge and Experience (Essential):

Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
Good knowledge of international guidelines ICH GCP as well as relevant local regulations.

Knowledge and Experience (Desirable):

Good medical knowledge and ability to learn relevant Client Therapeutic Areas.
Good knowledge of the Drug Development Process.
Excellent understanding of the Clinical Study Process including monitoring.
Very good understanding of the Study Drug Handling Process and the Data Management Process.
Good intercultural awareness.

Education:

Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification (or equivalent adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers.

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regulatory affairs empleos

Local Study Associate Director - FSP

Country Approval Specialist / Sr Country Approval Specialist

Sr Product Manager - Biosimilars

Head of Trade LATAM & Pharma Mexico

Site Activation Specialist - Futures Roles (Mexico)

Customs Analyst

Product Manager (Mexico City)

Medical Director (Endocrinology)

Sr Associate - Consumer Digital Ecosystem

Office Manager

Senior Clinical Data Engineer (LATAM)

Technical Services Analyst

Diseñador Gráfico Freelance

Senior Clinical Data Engineer (LATAM)

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