Exploring the Role of a Medical Writer I in Clinical Trial Transparency at Syneos Health
In the dynamic landscape of biopharmaceutical solutions, the role of a Medical Writer I (Clinical Trial Transparency) holds immense significance. Syneos Health, a fully integrated biopharmaceutical solutions organization, is on a mission to accelerate customer success and bring innovative therapies to patients. This article unveils the responsibilities, qualifications, and key aspects of this pivotal role at Syneos Health.
The Crucial Role of a Medical Writer II
Position: Medical Writer I (Clinical Trial Transparency)
Location: India-Asia Pacific – IND-Home-Based
Job ID: 23006852
Syneos Health: A Purpose-Built Organization
Syneos Health stands as a unique organization designed to fast-track customer success in the biopharmaceutical realm. It is dedicated to infusing high-value insights into its product development mindset, ultimately expediting the journey of therapies from development to patients. The company’s ethos revolves around making a tangible impact on patients’ lives by collaborating with passionate problem solvers.
Commitment to Total Self Culture
At Syneos Health, fostering a Total Self culture is paramount. This culture values authenticity, diversity of thoughts, and a sense of belonging. The company is committed to taking care of its employees, offering career development, supportive management, technical and therapeutic training, and a total rewards program.
The role of a Medical Writer I at Syneos Health involves a range of responsibilities:
- Compiling, writing, and editing medical writing deliverables with moderate supervision.
- Demonstrating a fair understanding of the drug development process and clinical research terminologies.
- Reviewing statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency.
- Collaborating with various departments including data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables.
- Adhering to regulatory standards, company SOPs, and client standards.
- Conducting clinical literature searches online.
- Maintaining continuous professional development to stay updated with regulatory guidance and client expectations.
- Managing budget specifications for assigned projects and communicating changes to leadership.
- Proficiency in MS Office, communication, and writing skills.
- Performing other assigned work-related duties.
Qualifications and Expectations
We are looking for candidates who possess the following qualifications:
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- 02 year of experience in medical writing.
- Looking for candidates with minimum 2-year experience medical writer
- Should have good knowledge of redactions/anonymization of clinical documents.
- Should have experience in preparing disclosure documents for clinicaltrials.gov and for various other clinical registries will be added advantage.
- Good understanding of Clinical Trial Disclosure.
- Good knowledge of regulatory requirements and guidance relevant to the service line.
- A strong understanding of clinical development processes, including principles of clinical study operations and ICH-GCP guidelines.
- Clear written and verbal communication skills.
- Working knowledge of basic computer applications, e.g., MS Word, PowerPoint, Excel, Adobe.
- The ability to understand and comprehend protocols and clinical study reports from a disclosure perspective.
- A good understanding of clinical trial disclosure fundamentals.
Core competencies for this role include:
- Analytical capabilities with scientific and clinical data.
- Operating in a professional working environment.
- Taking ownership of the allocated work.
- Commitment to delivering the highest quality outputs, with a strong attention to detail.
- Enthusiasm and proactivity.
- Effective team working.
- Building rapport and relationships with project-specific client colleagues.
Joining the Syneos Health Team
A career as a Medical Writer I (Clinical Trial Transparency) at Syneos Health offers an exciting opportunity to contribute to the advancement of healthcare. Collaborate with a global team of professionals who are dedicated to making a positive impact on patient lives. If you have a passion for medical writing and a commitment to excellence, consider joining the Syneos Health family.
How to Apply
To apply for the position of Medical Writer II (Clinical Trial Transparency / Redaction) at Syneos Health,