Local Site Activation Officer - Madrid, España - Allucent

Allucent

Empresa verificada

Madrid, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Descripción

CATO SMS and Pharm-Olam, LLC have merged to form Allucent

These customers have new therapeutic ideas but want a partner who can assist with the clinical trial process, the complexities of certain disease states, or other critical capacities.

You'll work with them on the newest treatment breakthroughs for some of the most perplexing conditions. And ultimately, you'll help make a positive difference in patients' lives.

Typically under the direction of a COM/CRM, the Local Site Activation Officer is responsible for assisting, (depending on the 4 grades of specialization identified below) in all related site activation activities at a local level.

The Local Site Activation Officer can use different tools in CTMS during the Site Activation Lifecycle and will be responsible in assisting to keep the Site Activation Milestones on track during the course of the study(s) thereby ensuring that expectations are met while identifying and mitigating the start up risks.

Key Responsibilities:

Assist in preparing, compiling and submitting regulatory documentation:
Review technical, pre-clinical and clinical reports for regulatory submissions.
Assist regulatory and clinical consultants where necessary.
Compliance review of SmPCs and review of product labels.
Assist in interactions with regulatory authorities
Access regulatory agency websites and/or contact regulatory authority at regular intervals for updates on regulations, guidelines and procedures. Ensure these changes and updates are communicated and circulated as appropriate.
Assist in preparing, compiling answers for questions raised by the Regulatory Agency and submit the answers.

Requirements:

Life Science degree or equivalent qualification or certification in a related allied health profession from an appropriate accredited institution
More than 2 years of experience in regulatory affairs in the pharmaceutical or biotechnology industry
A thorough knowledge of the country or region competent authority submission and reporting requirements and guidelines
A thorough understanding of the drug development process
Good oral and written communications skills fluent in Spanish and business proficient in English
Attention to detail
Able to perform well as a team member

Benefits

Comprehensive benefits package
Competitive salaries per location
Departmental Study/Training Budget for furthering professional development
Flexible Working hours (within reason)
Opportunity for hybrid working model
Improved worklife balance
Internal growth opportunities and career progression
More task variety
Financially rewarding internal employee referral program
Access to online softskills and technical training via GoodHabitz and internal platforms
To all recruitment agencies: Allucent does not accept agency resumes. Please do not forward resumes to our careers alias or other Allucent employees. Allucent is not responsible for any fees related to unsolicited resumes._

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