Manager Medical Affairs

Description

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
  
  

Job Responsibilities

• Manages operations of the Medical Affairs department, including representing the department internally for sponsor opportunities, managing department resources, monitoring utilization and realization, participating in process development and increasing the department’s overall efficiency:
• Support India with budgeting (clinical budget & medical management- FTE CSU) and resource allocation for Science Hub·
• Generate and provide accurate and timely performance metrics report for the medical affairs function across India.
• Work closely cross functionally with finance, legal, compliance and commercial on various organizational initiatives.
• Manage capability building and skill enhancement programs.
• Working with internal & external stakeholders for creating and implementing project plans for related medical/science events
• To support and assist Science Head in Operations.
  
  

Essential Functions

• Medical Governanc
• Support roll out of medical governance and medical operations related SOPs and their implementation across the affiliate
• Coordinate medical governance projects across India
• Assisting Medical Team in Managing Medical Approvals:
• Collaborated with the medical team to meticulously review and oversee medical approvals within the TRIMM system for critical interactions with Healthcare Professionals (HCPs), Healthcare Organizations (HCOs), and Master Service Agreements (MSAs). Provided vital support in ensuring compliance with regulatory standards and company policies.
• Conducting Comprehensive TRIMM Analysis:
• Conducted thorough analyses within the TRIMM platform, meticulously aligning with compliance standards and audit recommendations. Implemented meticulous scrutiny to identify areas for improvement and ensure adherence to regulatory requirements.
• Document Review and Archival:
• Played a pivotal role in the meticulous review and archival of documents pertaining to events within the TRIMM system. Ensured accurate documentation and organization of critical information for future reference and compliance purposes.
• Collaboration with TRIMM ITS Team:
• Fostered close collaboration with the TRIMM Information Technology Services (ITS) team, actively contributing insights and feedback for system enhancements, changes, and streamlining processes. Played a key role in facilitating communication between stakeholders and technical teams to ensure effective implementation of improvements.
• Reviewing GRFs:
• Conducted comprehensive reviews of Grant Request Forms (GRFs), ensuring accuracy, completeness, and compliance with internal and external regulations. Provided valuable input to streamline processes and enhance efficiency in grant management procedures.
• Cross-Functional Communication:
  
  

Facilitated seamless communication and collaboration across departments including Sales, Marketing, and Live Monitoring teams. Acted as a liaison to ensure alignment of objectives, exchange of vital information, and coordinated efforts towards achieving organizational goals.

Qualifications

What we’re looking for

• Minimum bachelor's degree
• Minimum 5 years prior related experience in pharmaceutical industry, preferably in medical affairs role.
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
  
  

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.

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.