Medical Affairs Specialist

Medical Affairs Specialist - India, Chennai/Trivandrum - Office or Home Based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're 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 development

Overview:

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 standards

Responsibilities:

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 office

What ICON can offer you:

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 we've done to become a more inclusive organisation. We're 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.

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