Medical Specialist

5264 Syneos Health India Private Limited; Gurugram District; In loco; INR 900.000 - 1.300.000; Tempo pieno

Descrizione del lavoro

Syneos Health India Private Limited is seeking a Medical Specialist to manage TMF filing and assist in medical management tasks. You will support eligibility reviews, data reviews, and document management, ensuring compliance with data privacy and GCP guidelines.

The role requires a postgraduate in biological sciences or related field, with 1–2 years of clinical research experience preferred, and strong proficiency in MS Office.

Competenze

• Postgraduate in biological sciences or related healthcare discipline essential.
• Solid office/administrative experience.
• 1–2 years of clinical research experience preferred.
• Knowledge of drug development and medical terminology.
• Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Strong communication, organisational and interpersonal skills.
• Ability to multitask and meet tight deadlines in a dynamic environment.

Mansioni

• Perform TMF filing of study documents and assist with TMF audits.
• Assist Medical Management with eligibility review and project activities.
• Support medical review queries and data review tasks.
• Manage shared mailbox and coordinate study meetings; prepare minutes.
• Upload documents to TrialEAS and other systems; ensure data privacy and GCP compliance.

Conoscenze

Clinical research experience

Microsoft Office proficiency

Communication skills

Organisational skills

Formazione

Postgraduate in biological sciences or related field

Nursing degree

Strumenti

Microsoft Word

Excel

PowerPoint

Descrizione del lavoro

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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work along side the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.