Fsp - Sr. Regulatory & Start Up Specialist

3+ years

Not Disclosed

Buenos Aires

9 Nov. 23, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Regulatory & Start-Up Specialist

Job Overview

The Regulatory & Start-Up Specialist is responsible for performing country-level tasks associated with Site Activation (SA) activities. This includes ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual/budgetary guidelines. The role may also involve maintenance activities throughout the project lifecycle.

Essential Functions

Single Point of Contact (SPOC) Role
- Serve as the Single Point of Contact for assigned studies, working with investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
- Ensure adherence to SOPs, Work Instructions (WIs), and quality standards for deliverables and project timelines.
Site Activation & Start-Up Activities
- Perform site activation tasks according to applicable regulations, SOPs, and work instructions.
- Distribute completed documents to sites and internal project teams, ensuring all required regulatory documents are properly prepared and accurate.
Regulatory Documentation Management
- Review and ensure the accuracy of site regulatory documents, ensuring completeness and compliance with project requirements.
- Maintain accurate records in internal systems, databases, and tracking tools with project-specific information.
Project Planning & Timeline Management
- Collaborate with the team to establish and review project planning and timelines, ensuring monitoring measures are in place.
- Implement contingency plans as needed and track the progress of site approvals and document execution, including regulatory, ethics, Informed Consent Forms (ICF), and Investigator Pack (IP) releases.
Local Expertise & Quality Control
- Provide local regulatory expertise to SAMs and project teams during initial and ongoing project planning.
- Perform quality control of documents provided by sites to ensure they meet regulatory and project standards.
Sponsor Communication
- May have direct contact with sponsors for specific initiatives, providing timely updates and addressing any concerns.

Qualifications

Education:
- Bachelor’s Degree in life sciences or a related field.
Experience:
- A minimum of 3+ years of clinical research experience in the regulatory field within Argentina, including:
  - Local regulatory submissions
  - Informed Consent Form (ICF) customization
  - Presentations to ethics committees and ANMAT
Skills and Competencies:
- Fluent in English with strong written and oral communication skills.
- Ability to work independently and prioritize tasks effectively.
- Strong attention to detail and quality control.
- Knowledge of local regulatory guidelines, GCP/ICH, and the clinical trial process.

This role is ideal for a professional looking to apply their regulatory expertise in a dynamic and supportive environment, ensuring compliance and successful site activation across clinical research studies.

Latest Jobs

Pharma Jobs in India

Andra Pradesh :

Assam :

Dibrugarh | Diburghar | Guwahati |

Bihar :

Hajipur | Patna |

Chhattisgarh :

Bilaspur | Raipur |

Delhi :

Delhi | India | New Delhi | PAN-India |

Goa :

Goa | Panaji |

Gujarat :

Haryana :

Himachal Pradesh :

Solan |

Jharkhand :

Ranchi |

Karnataka :

Kerala :

Kannur | Kochi | Malappuram | Thiruvananthapuram |

Madhya Pradesh :

Maharashtra :

PAN-India :

Panjab :

Punjab :

Rajasthan :

Banasthali | Jaipur | Pilani | Udaipur |

Tamil Nadu :

Uttar Pradesh :

Uttarakhand :

Dehradun | Nainital | Rishikesh |

West Bengal :

Kolkata | Mukundapur |

Pharma Jobs in United States

Alabama :

Birmingham |

Alaska :

Arizona :

California :

Colorado :

Denver |

Connecticut :

Groton | Storrs |

D.C :

Washington |

Florida :

Georgia :

Atlanta |

Hawaii :

Honolulu |

Illinois :

Indiana :

Bloomington | West Lafayette |

Kansas :

Lawrence |

LA :

Monroe | New Orleans |

Maryland :

Baltimore | Elkridge | Gaithersburg | Rockville |

Massachusetts :

Michigan :

Detroit |

Minnesota :

Minneapolis and St. Paul, Minnesota. |

Missouri :

Fulton | St. Louis |

New Jersey :

New York :

North Carolina :

Concord |

North Caroline :

Ohio :

Cincinnati | Cleveland | Columbus, |

Oregon :

Pennsylvania :

Portugal :

Lisbon | Portugal |

Puerto Rico :

San Juan |

Republic of Mexico :

Mexico |

Tennessee :

Nashville |

Texas :

Austin | Dallas | Houston | Richardson |

United states :

United States |

Virginia :

Blacksburg | Charlottesville | Falls Church |

Washington :

Goldendale | Pullman | Seattle |

WI :

Madison | Wausau |

Wisconsin :

Wyoming :

Cokeville |

Pharma Jobs in Germany

Baden-Wurttemberg :

Bavaria :

Berlin :

Mitte |

Brandenburg :

Berlin |

Germany :

Germany | GErmany |

Hesse :

Marburg |

Hessen :

Frankfurt |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Mecklenburg Vorpommern :

Rostock |

Munich :

Bavaria |

North Rhine Westphalia :

Rhineland Palatinate :

Mainz |

Rotherbaum :

Hamburg |

Saarland :

Saarbrucken |

Saxony Anhalt :

Halle |

Schleswig Holstein :

Kiel |

Pharma Jobs in Europe

BULGARIA :

Bulgaria |

Denmark :

Copenhagen |

Finland :

Finland |

Hungary :

Budapest |

Istanbul :

Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Serbia :

Belgrade | Serbia |

Switzerland :

Basel | Zurich |

Pharma Jobs in China

Hubei :

Wuhan |

Republic of China :

Beijing |

Shanghai Sai :

Shanghai Shi |

Tokiyo :

Osaka | Tokyo |

Pharma Jobs in Argentina & Australia & Canada & Colombia & Croatia & Egypt & England & Estonia & France & Indonesia & Ireland & Israel & Japan & Korea & Netherland & Portugal & Remote & Saudi Arabia & Spain & Thailand

Buenos Aires :

Buenos Aires |

New South Wales :

Sydney |

Queensland :

Queensland |

Republic of Western Australia :

Nedlands |

Canada :

Canada |

Ontario :

Richmond Hill | North York |

Quebec :

Montreal |

Republic of Colombia :

Bogota |

Zagreb :

Zagreb |

Republic of Egypt :

Cairo |

United Kingdom :

Harlow | London | Salt Lake City |

Estonia :

Estonia |

France :

Paris |

Jakarta :

Jakarta |

County Dublin :

Swords |

Republic of Ireland :

Limerick | Waterford | Dublin |

Israel :

Be'Er Sheva | Netanya | Tel Aviv | Kfar Saba |

Tokyo :

Otemachi |

Republic of Korea :

Seoul |

Capital of Netherland :

Amsterdam |

Noord Holland :

Haarlem |

Remote :

Remote | Switzerland | Remote - Europe | Remote, USA |

Makkah :

Catalonia :

Barcelona |

Madrid :

Madrid |

Republic of Thailand :

Bangkok |

Fsp - Sr. Regulatory & Start Up Specialist

Job Description

Job Description: Regulatory & Start-Up Specialist

Job Overview

Essential Functions

Qualifications

Latest Jobs

Director Of Billing & Coding Compliance

Medical Billing Collection Manager

Coder Ii - Op Physician Coding

Sr Biostatistician

Project Associate I

Sr Cra I (Estonia) - Sponsor-Dedicated

Stat Programmer 2

Cra Ii