Local Site Activation Officer
Allucent, Spain
Job Description
CATO SMS and Pharm-Olam, LLC have merged to form Allucent!
Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies.
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 the Global Regulatory Manager (GRM) in the preparation, compilation, submission and maintenance of regulatory documentation required by regulatory agencies for clinical trials and marketing applications at local level
- Assist in preparing, compiling and submitting regulatory documentation:
- Assist in the preparation of local clinical trial applications.
- Ensure relevant documents in compliance with local regulation, including but not limited to clinical trial applications, study drug labels, study drug related documentation, etc. are being provided appropriately.
- 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 work-life balance
- Internal growth opportunities and career progression
- More task variety
- Financially rewarding internal employee referral program
- Access to online soft-skills 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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