• Login / Signup
    • Instagram
    youtube
    Facebook

    Regulatory Affairs Project Manager

    Medpace
    2+ years
    Preffered by Company
    Remote
    10 Aug. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/Any 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 Title: Regulatory Project Manager

    Location: Cincinnati, OH (Office-Based)

    Company Overview:

    Medpace is a leading full-service Contract Research Organization (CRO), providing comprehensive Phase I-IV clinical development services to the biotechnology, pharmaceutical, and medical device industries. Headquartered in Cincinnati, Ohio, we have over 5,000 employees across 40+ countries. Our mission is to accelerate the global development of safe and effective medical therapeutics through a scientific and disciplined approach. We specialize in various therapeutic areas, including oncology, cardiology, metabolic diseases, endocrinology, central nervous system disorders, and anti-viral and anti-infective treatments.

    Role Summary:

    We are experiencing rapid growth and are looking for a full-time, office-based Regulatory Project Manager to join our Cincinnati team. In this role, you will be a vital member of our Regulatory Affairs project teams, managing key tasks essential to the success of our projects. This position offers an opportunity to leverage your expertise and further develop your career within the drug development industry.

    Responsibilities:

    • Regulatory Submissions: Coordinate regulatory submissions and act as the primary contact between Sponsors and the US FDA.
    • IND Applications: Manage Investigational New Drug (IND) application activities, track and report project status, and establish comprehensive timelines.
    • Meetings Coordination: Schedule and lead internal and external project team meetings, preparing agendas, presentation materials, and meeting minutes.
    • Collaboration: Work closely with Regulatory Strategy Leads, Medical Writers, and Regulatory Document Specialists to execute project plans.
    • Communication: Maintain clear and effective communication with Sponsors, anticipate potential issues, and work with the team to develop solutions.
    • Team Integration: Foster close collaboration with Medpace functional area colleagues and represent Regulatory Affairs in clinical operations internal meetings.
    • Support: Contribute to other departmental initiatives as needed.

    Qualifications:

    • Education: Bachelor’s Degree in life sciences with a minimum of 2 years of regulatory experience, or a PhD in life sciences.
    • Experience: Knowledge of the US FDA drug/biologic approval process and experience with IND applications.

    Why Medpace?

    Join us at Medpace where People, Purpose, and Passion drive our mission to make a difference in the world of clinical research. We are dedicated to improving the lives of patients through innovative and effective medical therapeutics.

    Cincinnati Perks:

    • Work Flexibility: Hybrid work-from-home options based on position and level.
    • Generous PTO: Competitive paid time off packages starting at 20+ days.
    • Compensation: Attractive salary and benefits package.
    • Work-Life Balance: Flexible work schedules, company-sponsored employee appreciation events, and wellness initiatives.
    • Community Engagement: Opportunities for involvement with local nonprofit organizations and discounts on local sports events, fitness gyms, and attractions.
    • Campus Benefits: Enjoy a modern, eco-friendly campus with an on-site fitness center.
    • Career Development: Structured career paths, professional growth opportunities, and discounted tuition for UC online programs.

    Awards and Recognition:

    • Top Workplace: Named a Top Workplace in 2024 by The Cincinnati Enquirer.
    • Forbes Recognition: Recognized by Forbes as one of America's Most Successful Midsize Companies (2021-2024).
    • CRO Leadership Awards: Continually honored with CRO Leadership Awards from Life Science Leader magazine for expertise, quality, capabilities, reliability, and compatibility.

    Apply Today:

    If you are a dedicated and experienced Regulatory Project Manager with a passion for clinical research and regulatory affairs, we invite you to apply and become part of our dynamic team at Medpace.

    Make a Difference Tomorrow. Join Us Today.

    Latest Jobs

    Inpatient /Outpatient Medical Coder (Remote) - Cpc

    Momentum Resource Solutions
    New York

    Account Manager - Molecular Genetics - Billing/Revenue Cycle Mgt

    Tesis Labs Llc
    Albany

    Specialty Clinic Coding Spec (Remote)

    Mercy Hospital
    Fort Smith

    Remote Orthopedic Coder

    The Coding Network Llc
    Charlotte

    Professional Coder Orthopedic Surgery

    M&D Capital Premier Billing
    Richmond Hill

    Ip Hims Coder - Remote

    Cornerstone Staffing
    Dallas

    Medical Billing A/R Specialist - Pending Claims - Remote/Hybrid

    Qmacs
    Richardson

    Medical Billing Coder

    A To Z Pediatrics, Llc
    Oklahoma City

    Podiatrist

    360care
    Houghton Lake

    Certified Medical Coder (Remote Ony Socal Candidates Accepted)

    Prosum
    Los Angeles

    Pharma Jobs in India

    Andra Pradesh :

    Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Tirupathi | Visakhapatnam |

    Assam :

    Dibrugarh | Diburghar | Guwahati |

    Bihar :

    Hajipur | Patna |

    Chhattisgarh :

    Bilaspur | Raipur |

    Delhi :

    Delhi | India | New Delhi | PAN-India |

    Goa :

    Goa | Panaji |

    Gujarat :

    Ahmedabad | Baroda | Gandhinagar | Mehsana | Tarasadi | Vadodara | Vapi |

    Haryana :

    Ambala | Hisar | Kurukshetra | Panchkula | Rohtak |

    Himachal Pradesh :

    Solan |

    Jharkhand :

    Ranchi |

    Karnataka :

    B.G Nagara | Bangalore | Belgaum | Bengaluru | Mangaluru | Mysore | Udupi |

    Kerala :

    Kannur | Kochi | Malappuram | Thiruvananthapuram |

    Madhya Pradesh :

    Dewas | Gwalior | Indore | Khandwa | Khargone | Ujjain |

    Maharashtra :

    Ambernath | Amravati | Aurangabad | Jalgaon | Kolhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tarapur | Thane |

    PAN-India :

    Panjab :

    Punjab :

    Bathinda | Bela | Chandigarh | Moga | Mohali | Patiala | Phagwara | Rajpura |

    Rajasthan :

    Banasthali | Jaipur | Pilani | Udaipur |

    Tamil Nadu :

    Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Srivilliputtur | Tiruchirappalli | Trichy |

    Uttar Pradesh :

    Gajraula | Gautam buddha Nagar | Ghaziabad | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Varanasi |

    Uttarakhand :

    Dehradun | Nainital | Rishikesh |

    West Bengal :

    Kolkata | Mukundapur |

    Pharma Jobs in United States

    Alabama :

    Birmingham |

    Alaska :

    Anchorage | Barrow | Bethel | Juneau | Wrangell |

    Arizona :

    Chandler | Kingman | Lake Havasu City | Peridot | Phoenix | Tempe | Tucson | Yuma |

    Arkansas :

    Fort Smith |

    California :

    Brisbane | Crescent City | Davis | El Monte | El Segundo | Emeryville | Foster City | Fremont | Irvine | La Jolla | Los Angeles | Martinez | Mountain View | Nevada | Oakland | Pacheco | Palo Alto | Pasadena | Pleasanton | Redwood City | Riverside | Sacramento | San Bernardino | San Diego | San Francisco | San Gabriel | San Jose | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | Stanford | Vallejo | West Valley City | Whittier | Willits |

    Colorado :

    Denver |

    Connecticut :

    Groton | Storrs |

    D.C :

    Washington |

    Florida :

    Clearwater | Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Stuart | Tallahassee | Tampa | West Palm Beach |

    Georgia :

    Atlanta |

    Hawaii :

    Honolulu |

    Illinois :

    Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville | Round Lake |

    Indiana :

    Bloomington | West Lafayette |

    Kansas :

    Lawrence |

    Kenlucky :

    Shelbyville |

    LA :

    Monroe | New Orleans |

    Maryland :

    Baltimore | Elkridge | Gaithersburg | Rockville |

    Massachusetts :

    Boston | Cambridge | Devens | Lexington | Medford and Somerville | Rockland |

    Michigan :

    Detroit | Houghton Lake |

    Minnesota :

    Minneapolis and St. Paul, Minnesota. |

    Missouri :

    Fulton | St. Louis |

    New Jersey :

    Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |

    New York :

    Albany | Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Rensselaer | Syracuse |

    North Carolina :

    Concord |

    North Caroline :

    Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |

    Ohio :

    Cincinnati | Cleveland | Columbus, |

    Oklahoma :

    Oklahoma City |

    Oregon :

    Bend | Corvallis | Eugene | Roseburg | Springfield |

    Pennsylvania :

    Ambler | Lancaster | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | West Chester | Wyomissing |

    Portugal :

    Lisbon | Portugal |

    Puerto Rico :

    San Juan |

    Republic of Mexico :

    Mexico |

    South Carolina :

    Charleston |

    Tennessee :

    Nashville |

    Texas :

    Austin | Dallas | Houston | Richardson | Waco |

    United states :

    United States |

    United States :

    Hawai |

    Virginia :

    Blacksburg | Charlottesville | Falls Church |

    Washington :

    Goldendale | Pullman | Seattle |

    WI :

    Madison | Wausau |

    Wisconsin :

    Wyoming :

    Cokeville |

    Pharma Jobs in Germany

    Baden-Wurttemberg :

    Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |

    Bavaria :

    Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |

    Berlin :

    Mitte |

    Brandenburg :

    Berlin |

    Germany :

    Germany | GErmany |

    Hesse :

    Marburg |

    Hessen :

    Frankfurt |

    Lower Saxony :

    Gottingen | Hannover | Leipzig |

    Mecklenburg Vorpommern :

    Rostock |

    Munich :

    Bavaria |

    North Rhine Westphalia :

    Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |

    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 & Tennessee & Thailand

    Buenos Aires :

    Buenos Aires |

    New South Wales :

    Sydney |

    Queensland :

    Queensland |

    Republic of Western Australia :

    Nedlands |

    Canada :

    Canada |

    Ontario :

    North York | Richmond Hill |

    Quebec :

    Montreal |

    Republic of Colombia :

    Bogota |

    Zagreb :

    Zagreb |

    Republic of Egypt :

    Cairo |

    United Kingdom :

    Salt Lake City | London | Harlow |

    Estonia :

    Estonia |

    France :

    Paris |

    Jakarta :

    Jakarta |

    County Dublin :

    Swords |

    Republic of Ireland :

    Dublin | Waterford | Limerick |

    Israel :

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

    Tokyo :

    Otemachi |

    Republic of Korea :

    Seoul |

    Capital of Netherland :

    Amsterdam |

    Noord Holland :

    Haarlem |

    Remote :

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

    Makkah :

    Jeddah | Khulais | Rabigh | Najran | Riyadh |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |