Medical Monitor
American Cybersystems, Inc.

Job Info

Innova Solutions is immediately hiring a Medical Monitor

Job Title: Medical Monitor
Position type: Full-time Contract
Duration: 06 Months
Location: Princeton Pike, NJ
Pay range: $73.42 -$ 83.91 Per Hour

As a Medical Monitor you will:
• The Established Brands medical scientist-contractor is responsible for the medical oversight of activities for brands in late stages of life cycle and those which have undergone Loss-of-Exclusivity
Key Responsibilities:
• Lead medical input for brand cross-functional teams for assigned products.
• Provide medical input to patient safety monitoring of the brand and available literature findings, propose labeling recommendations based on signal detection activities and pharmacovigilance findings.
• Provide Medical Assessments of Risk/Benefit of assigned products regarding new indications, safety or stability issues, medical necessity/sensitivity assessments or other actions that require reappraisal of the product Risk/Benefit.
• Provide medical input for regulatory requirements, including Response to Health Authorities queries and support for registration renewals and label periodic reviews.
• Provide medical support to the Company Core Data Sheet content review and development.
• Provide medical evaluation and appropriate communications to additional documents and activities such as: Dear Health Care Professional letters, Clinical Overview for Type II variation, Periodic Benefit-Risk Evaluation regulatory document submissions and coordinate expert reports.
• Compliance Support delivery of medical affairs compliance needs for the assigned portfolio as appropriate.
Position Competencies:
• Demonstrate ability to apply Client operating philosophy, company shared values and operate within company policies and procedures and appropriate regulations.
• Strong ability to operate effectively within highly matrixed and collaborative environment:
o Partner with local market organizations as appropriate for medical deliverables and portfolio functions.
o Collaborate with key cross-functional partners, Global Regulatory, Global Labeling, Patient Safety, Quality & Compliance.
• Knowledgeable and skilled in medicine and pharmaceutical product preferably with experience in pharmaceutical industry and post-marketing safety.
• Ability to provide input to cross-disciplinary matrix teams, promote collegiality and teamwork among team members.
• Ability to think clearly and decisively and present independent, reasoned solutions to identified safety issues.
• Familiarity with regulatory guidelines.

Qualifications:
• MD or Equivalent required
• Board certification and medical specialty highly preferred
• 2-4+ years in clinical practice
• 1-2+ years of pharmaceutical industry experience required with 5+ years preferred
• 1-2+ years of clinical safety experience strongly preferred, with experience with pharmacovigilance-safety
• Experience in multi-brand experience would be an advantage.
Additional Job Requirements:
None
Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you!
Sara Almas
Team Recruitment
Sara.Almas@innovasolutions.com

PAY RANGE AND BENEFITS:
Pay range: $73.42 -$ 83.91 Per Hour

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centers across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:
One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
ClearlyRated® Client Diamond Award Winner (2020)
One of the Largest Certified MBE Companies in the NMSDC Network (2022)
Advanced Tier Services partner with AWS and Gold with MS
Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at hr@innovasolutions.com or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b.
The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.