Job Description

Medical Affairs Specialist - India, Chennai/Trivandrum - Office or Home BasedICON plc is a world-leading healthcare intelligence and clinical research organization. Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentOverview:Provide support to Medical Affairs (MA) management and Medical Monitors in all aspects of MA activities, as needed
Assist in providing medical/scientific consultation to internal and external customers with oversight from the medical monitor (MM) Ensure that daily medical management activities are completed in accordance with ICON
standards and other applicable standardsResponsibilities:The role:

• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance

• As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs

• Travel ( less than 10%) domestic and/or international

• *Serve as an integral part of the MA team

• *Demonstrate relevant protocol and product knowledge of assigned protocols with oversight and guidance from the Medical Monitor

• *Author and contribute to the preparation of core MA internal and external deliverables (MMPs, trackers, reports) as contracted

• Provide functional oversight for MA as directed by lead MM for specific studies

• Recognize potential issues relevant for MA project tasks and escalate according to the applicable procedure

• Provide input and review of relevant MA tracking systems for accuracy and quality and assist with maintaining MA project files

• Perform review of clinical and diagnostic data with oversight from the MM as it relates to patient safety

• Liaise with investigational site and/or Sponsor as necessary regarding MA issues with oversight and guidance from MM

• Participate in internal and external project team meetings and teleconferences, as required

• *Serve as a resource for investigational sites and ICON personnel on safety-related issues as they pertain to MA tasks with assistance and oversight from MM as required

• *Liaise with ICON project manager, and other departments, as appropriate

• Assist MM with weekly and monthly project status reports

• Contribute to presentations for start-up meetings, Investigator meetings and other meetings as requested

• Liaise with safety and regulatory teams in order to facilitate open communication regarding updates on SAEs and regulatory issues

• *Assist with financial oversight of projects (monthly unit metrics, Change Orders, out-of-scope activities and any other financial tracking)

• Review and demonstrate working knowledge of contract and GPT in conjunction with MM

• Coordination of periodic project review meetings

Qualifications:You will need:

• A Minimum of 2 years of experience of relevant clinical research industry experience

• Degree in Health
• Basic knowledge of medical terminology and coding systems
• Advanced English for Reading, Writing and Speaking
• Excellent written and verbal communication
• Advanced Office Pack
• Desirable experience in Pharma
• Knowledge of ICH guidelines

Note: Hybrid Position: 2 days at home, 3 days at the officeWhat ICON can offer you:Our success depends on the quality of our people. Thats why weve made it a priority to build a diverse culture that rewards high performance and nurtures talent.In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:Various annual leave entitlementsA range of health insurance offerings to suit you and your familys needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your familys well-being.Life assuranceFlexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.Visit our to read more about the benefits ICON offers.At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work weve done to become a more inclusive organisation. Were dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request .Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - theres every chance youre exactly what were looking for here at ICON whether it is for this or other roles.Are you a current ICON Employee? Please click to apply

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