Position Overview:
As a leading global contract research organization (CRO), Fortrea is dedicated to scientific excellence and has decades of clinical development experience. We offer a comprehensive range of clinical development, patient access, and technology solutions across over 20 therapeutic areas to pharmaceutical, biotechnology, and medical device clients. With more than 19,000 staff operating in over 90 countries, we are transforming drug and device development for partners and patients worldwide.
Key Responsibilities:
Safety Report Management: Write and review various safety reports for global regulatory submissions, including Annual Reports (IND and others), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Clinical Overviews, Medical Device reports, and other assigned documents.
Report Production Oversight: Lead the entire report production process, ensuring quality standards and timelines are met. Provide oversight to co-authors or writing teams and be accountable for the quality of their contributions.
Client Liaison: Serve as the primary contact for clients regarding report management activities. Communicate effectively with stakeholders to manage expectations, address challenges, propose solutions, and escalate unresolved issues impacting deliverables.
Risk Management Plans (RMPs): Author and review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, and effectiveness reports for risk minimization or enhanced pharmacovigilance activities.
Signal Management Participation: Engage in various steps of the signal management process, including developing signal strategies and retrieving data from safety databases and scientific literature. Author and review signal evaluation and safety issue analysis reports.
Safety Review Meetings: Participate in safety and benefit-risk review meetings with clients, discussing findings and collaborating with safety physicians to propose label updates and risk mitigation measures.
Health Authority Responses: Draft responses to health authority inquiries and collaborate with cross-functional teams to manage and track feedback.
Scientific Contributions: Develop abstracts, posters, manuscripts, and other materials for scientific publications or presentations at conferences. Prepare medical information responses for healthcare professionals.
Writing Coaching: Act as a writing coach, providing regular quality feedback, conducting training, and sharing best practices to promote clear and concise writing while adhering to style guides.
Project Management Support: Assist in maintaining project schedules and tracking metrics to ensure compliance with project requirements.
Business Development Contributions: Engage in business development activities, including resource estimation and responding to RFPs.
Label Creation and Updates: Create and update labels such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.
Literature Reviews: Conduct literature reviews and formulate search strategies for complex research topics.
Process Improvement: Implement consistent and efficient quality processes to meet timelines and deliverables while ensuring compliance with regulatory requirements.
Customer Service Excellence: Foster a culture of high customer service within the organization.
Additional Duties: Perform other related tasks as needed or assigned by management.
Join Us: Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our commitment to advancing clinical trials. We are dedicated to revolutionizing the development process to ensure the rapid delivery of life-changing therapies to patients. Join our exceptional team and thrive in a collaborative environment that fosters personal growth and global impact.
For more information about Fortrea, visit www.fortrea.com.
Equal Opportunity Employer: Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in our workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, color, national origin, gender (including pregnancy or medical conditions), family or parental status, marital status, sexual orientation, gender identity, age, veteran status, disability, or any other legally protected characteristic. We encourage all to apply.
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 |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 |Alaska :
Anchorage | Barrow | Bethel | Juneau | Wrangell |Arizona :
Chandler | Kingman | Lake Havasu City | Peridot | Tempe | Tucson | Yuma |California :
Brisbane | Crescent City | Davis | El Monte | 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 :
Storrs |D.C :
Washington |Florida :
Coral Gables | Gainesville | Jacksonville | Naples | Orlando | Rueil-Malmaison | Tallahassee | Tampa | West Palm Beach |Georgia :
Atlanta |Hawaii :
Honolulu |Illinois :
Abbott Park | Champaign | Chicago | Deerfield | Lombard | Naperville |Indiana :
Bloomington | West Lafayette |Kansas :
Lawrence |LA :
Monroe | New Orleans |Maryland :
Baltimore | Elkridge | Rockville |Massachusetts :
Boston | Cambridge | Medford and Somerville | Rockland |Minnesota :
Minneapolis and St. Paul, Minnesota. |Missouri :
Fulton | St. Louis |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | 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 :
Biddle | Buffalo | Hicksville | Ithaca | Morningside Heights | New York | Syracuse |North Caroline :
Chapel Hills | Durham | Morrisville | Philippines | Raleigh | Scottsdale |Ohio :
Columbus, |Oregon :
Bend | Corvallis | Eugene | Roseburg | Springfield |Pennsylvania :
Ambler | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Wyomissing |Puerto Rico :
San Juan |Republic of Mexico :
Mexico |Tennessee :
Nashville |Texas :
Austin | Dallas | Houston | Richardson |Virginia :
Blacksburg | Charlottesville | Falls Church |Washington :
Goldendale | Pullman | Seattle |WI :
Madison | Wausau |Wisconsin :
Wyoming :
Cokeville |Baden-Wurttemberg :
Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |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 |Denmark :
Copenhagen |Hungary :
Budapest |Istanbul :
Turkey |Serbia :
Belgrade |Switzerland :
Basel | Zurich |New South Wales :
Sydney |Queensland :
Queensland |Republic of Western Australia :
Nedlands |Hubei :
Wuhan |Republic of China :
Beijing |Tokiyo :
Tokyo | Osaka |Republic of Colombia :
Bogota |Zagreb :
Zagreb |Republic of Egypt :
Cairo |United Kingdom :
London | Salt Lake City |Republic of Ireland :
Limerick | Dublin |Republic of Korea :
Seoul |Capital of Netherland :
Amsterdam |Remote :
Remote - Europe | Remote | Remote, USA | Switzerland |Makkah :
Riyadh | Rabigh | Najran | Khulais | Jeddah |Catalonia :
Barcelona |Republic of Thailand :
Bangkok |