Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

Responsibilities

• Leads or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to: clinical planning, protocol development, case report form (CRF) development, IRB submissions, investigator agreements, informed consent form (ICF) development, site selection and communication with clinical trial sites regarding all logistics including contract agreements, support materials and training

• Provides clinical oversight and management for clinical trials to facilitate compliance with FDA and other applicable international regulatory requirements and company standard operating procedures (SOPs) during all company clinical investigations and post-market studies

• Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management of follow-up and close out study visits to ensure compliance with protocols and GCP requirements

• Collaborates on clinical data processing in accordance with departmental SOPs and guidelines

• Verifies, reviews and tracks CRFs and generates Data Clarification Forms (DCFs) for all missing or inaccurate data; ensure that data changes are properly implemented and captured in the database or data system

• Assists in the evaluation and analysis of clinical trial data to facilitate completion of clinical trial reporting requirements, including report writing, clinical photo-documentation, FDA and manuscript submissions

• Assists in tracking study specific payments

• Provides operational or workflow support to assure that departmental and cross functional systems and procedures are efficiently and correctly completed

• Collaborates on project teams, primarily with Clinical Operations, Research and Development, Safety, Clinical Trial Materials, Marketing, Regulatory and Quality/Compliance

• Leads or collaborates on technical writing projects which include white papers, abstracts, manuscripts, and literature reviews

• Liaison between internal and external stakeholders to facilitate cooperation of others

• Conducts presentations of clinical information concerning specific projects

• Works on projects of moderate-to-high degree of difficulty in which analysis of situation or data requires review of identifiable clinical factors and in which scientific and clinical perspectives should be incorporated

Qualifications

• Bachelor’s degree in a health profession or science. Advanced degree preferred.

• At least 5 years of on-going clinical trials experience in the pharmaceutical or device industry. Both are preferred.

• Demonstrated proficiency in knowledge of GCPs and knowledge of FDA regulatory requirements.

• Knowledge of medical terminology.

• Ability to effectively work independently

• Excellent verbal and written communication skills plus computer proficiency (Word, Excel, Outlook) and data management experience.

• 10%-30% travel required.

Language and Verbal Skills:

• Individual must have good verbal skills and written skills plus a demonstrated ability to communicate clearly and professionally.

Analytical and Reading Skills:

• Ability to read, analyze, interpret and assist in the creation and refinement of company procedures. Ability to identify problems, collect data, draw valid conclusions, and report on findings. Ability to assist in analysis of clinical trial data. Ability to interpret articles published in medical and scientific journals relative to projects and activities in Clinical Programs. Responsible for ensuring accuracy of medical and scientific information.

Physical Requirements:

• While performing the duties of this job the employee may be required to perform tasks involving lifting weights of up to 30 pounds for short durations. Duties of this job may involve standing and/or walking for extended periods of time. Duties also involve daily keyboard data entry. Specific vision abilities required by this job include close vision. Duties will also include air travel both domestically and internationally.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $120k - $155k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

#LI-remote

This position may be available in the following location(s): [[location_obj]]

Bausch Health Companies Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

If a candidate needs a reasonable accommodation/adjustment due to physical or mental health impairment for any part of the application process, they are encouraged to send their request to humanresources@bauschhealth.com or call 908-927-1400 and let us know the nature of the request and their contact information. Please be sure to include the job requisition number.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

To learn more please read Bausch Health's Job Offer Fraud Statement (https://protection.greathorn.com/services/v2/lookupUrl/c29afa19-107c-4ce0-9f8c-cdaacd1f6318/176/6d14a0b2d6ae791286e49cc8358d2a3ef29730f9) .

Bausch Health is an EEO/AA employer M/F/D/V.