Syneos Health Hiring Medical Writer I (CSR Narratives)

We are pleased to present an exciting career opportunity for the position of Medical Writer I (CSR Narratives) at Syneos Health, a leading biopharmaceutical solutions organization dedicated to accelerating customer success. This role is based in India-Asia Pacific and offers a unique chance to join a dynamic team focused on advancing therapies that improve patients’ lives. Below, you’ll find comprehensive details about this position to help you understand the role and qualifications required.

Position Title: Medical Writer I (CSR Narratives)

Location: India-Asia Pacific – IND-Home-Based

Job ID: 23006016

Description: At Syneos Health, we are committed to revolutionizing the biopharmaceutical industry by putting the customer and patient at the core of our operations. We work relentlessly to simplify processes and deliver high-value insights that expedite therapy development and enhance patient care.

As a Medical Writer I (CSR Narratives), you will play a pivotal role in compiling, writing, and editing various medical writing deliverables. You will collaborate across departments, ensuring the quality and accuracy of clinical documents such as study protocols, clinical study reports, patient narratives, and investigator brochures. Your contributions will be integral to the success of our mission to improve lives through medical innovation.

Why Syneos Health:

• Career development and progression opportunities
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• A commitment to the Total Self culture, where authenticity is valued
• A diverse and inclusive workplace that fosters a sense of belonging

Qualifications: We are seeking candidates with the following qualifications:

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.
• Extensive knowledge of English grammar with familiarity with AMA style guide.
• Understanding of FDA and ICH regulations and guidelines (strongly preferred).
• Demonstrated effective presentation, proofreading, and interpersonal skills, with a team-oriented approach.
• Strong proficiency in Word, Excel, PowerPoint, email, and Internet.
• Ability to demonstrate familiarity with principles of clinical research and interpret and present clinical data and other complex information.

Job Responsibilities: As a Medical Writer I (CSR Narratives), your key responsibilities include:

• Compiling, writing, and editing medical writing deliverables.
• Developing or supporting various documents, including clinical study protocols, clinical study reports, patient narratives, and investigator brochures.
• Reviewing statistical analysis plans and table/figure/listing specifications.
• Collaborating with department heads and staff members across departments.
• Adhering to regulatory standards, including ICH-E3 guidelines and company SOPs.
• Conducting online clinical literature searches, as applicable.
• Continuing professional development to stay updated with regulatory guidance.
• Managing project budgets and timelines effectively.
• Completing assigned administrative tasks within specified timeframes.
• Performing other work-related duties as assigned (minimal travel may be required).