Senior Specialist, Regulatory Affairs (Argentina)

Requisition Number: 2107

Position Title: Senior Specialist, Regulatory Affairs

External Description:

Site Activation is a fast growing, dynamic department!  We are the launch pad for new projects.  We help determine strategies for the optimal mix of countries, target sites and other factors to expedite regulatory and recruitment objectives, and then execute that strategy by initializing regulatory filings and locating, qualifying and activating clinical research sites.

The Site Activation group is the perfect place to launch or further your career.  We emphasize development of project management and strategic planning skills that will advance you though the opportunities within Site Activation or serve as an excellent pathway to advancement in Project Management or other Clinical Operations groups. 

SUMMARY: Accountable for site activation project management and delivery in the Site Activation and Regulatory (SAR) department. Project activities include site identification, investigator and site contracts, central and local EC submissions, Competent Authority submissions and any other country and/or study specific activities necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). It may also include proposal and budget management or feasibility/site identification activities. Reports to the Site Activation and Regulatory Therapeutic Lead or may report to a Site Activation Portfolio Manager if assigned to a portfolio or program of studies.

RESPONSIBILITIES:

• Serve as the primary point of communication and accountability for start-up and maintenance (if applicable) activities on assigned projects
• Lead and manage assigned SAR project teams to achieve successful delivery of milestone achievements and any key performance indicators
• May perform line management activities with responsibility for direct report performance, development and administrative compliance
• Oversee project activities of Regulatory Affairs Specialists and Site Activation Specialists to ensure critical path activities are completed on time
• Ensure accurate compilation, management and tracking of site activation activities in timely manner
• Work closely with assigned team members to expedite the Site Qualification and Selection process
• Effectively communicate Site Activation & Regulatory project status to the Sponsor, GPL/CPM and project team
• Prepare risk assessment and mitigation plans relating to project deliverables with input from other roles
• Work in conjunction with assigned project team members to develop site activation related project plans, such as the study-specific Site Activation Plan
• May contribute to the development, review, and maintenance of SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation department
• Provide input to departmental process improvement initiatives
• Interpret site activation metrics and drive corrective action to achieve deliverables or milestones and KPIs
• May participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals, budgets and other country and/or study specific activities related to Site Activation
• Report and/or escalate issues to Line Manager or Site Activation & Regulatory Therapeutic Lead according to project plans to ensure resolution and minimize risks to on-time deliverables
• Comply with SOPs, ICH GCP and national regulations as applicable
• Liaise with other functional contributors and vendors as needed

 

OTHER SKILLS AND ABILITIES:

• Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquing
• Ability to exercise sound judgment and make decisions independently and to proactively identify and solve problems
• Ability to provide experience and input into initiatives relating to interacting with sites and/or customers
• Ability to motivate, lead and engage a team
• Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
• Strong oral and written communication skills to clearly and concisely present information
• Demonstrated ability to collaborate across the business
• Team-oriented work style; seeks and gives guidance
• Understanding of regulatory processes, guidelines, and the application of local regulatory requirements
• Understanding of initiation, planning, and execution of clinical projects and overall project planning
• Awareness of ICH GCP Guidelines and the FDA/ EU Clinical Trials Directives/National regulations (CTAs,
• Amendments, Urgent Safety Measures, End of Trial Notifications)
• Ability to handle multiple tasks in a fast-paced and constantly changing environment
• Ability to work in an organized, methodical and self-motivated manner
• Proficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude

REQUIREMENTS:

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science, OR…
• Two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and eight years’ experience within clinical research (e.g. CRA, Reg Affairs.)
• Minimum of 3 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experience
• Proficient in cross-cultural communication
• Proficient in both spoken and written English

 

#LI-HD1

 

City:

State: Buenos Aires

Employment Type: Regular

Community / Marketing Title: Senior Specialist, Regulatory Affairs (Argentina)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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