Medical Specialist

Medical Specialist

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
 
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
 
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress. 

Job Responsibilities

Core Responsibilities

• Performs Trial Master File (TMF) filing of study-specific medical documents and relevant medical communications; may participate in TMF file audits.
• Assists Medical Management and Scientific Services staff with eligibility review and project management activities, including development of eligibility review forms and other study-related documents as needed.
• Supports medical review query management and other medical data review tasks as needed.
• Manages the shared mailbox and routes correspondence appropriately.
• Assists with coordination of medical management project meetings, attends meetings, prepares meeting minutes and action items, and maintains study-related documents.
• Uploads and manages documents collected for eligibility review into TrialEAS™ and other eligibility review support systems as needed.
• Adheres to all data privacy guidelines, International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) requirements, enterprise policies, standard operating procedures, work instructions, and project plans. Adheres to customer policies and standard operating procedures as required in project plans.

Additional Qualifications

• Postgraduate in biological sciences or a related natural sciences/healthcare discipline, nursing degree, or equivalent combination of education and experience is essential.
• Solid office/administrative experience.
• Previous 1–2 years of clinical research experience, such as CTA or study coordinator, is preferred but not mandatory.
• Knowledge of protocol- and disease-related terminology and the drug development process, including databases and medical terminology, would be an advantage.
• Advanced proficiency in Microsoft Office Suite, including Word, Excel and PowerPoint.
• Strong customer service skills with effective written and verbal communication appropriate to a professional medical setting.
• Strong organisational, presentation, documentation and interpersonal skills, with a team-oriented approach.
• Ability to multitask and meet tight deadlines in a dynamic environment while maintaining attention to detail and high-quality work.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.  The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.