Medical Writers Jobs Syneos Health – BSc Life Sciences Apply Online
Title: Medical Writer II (Clinical Trial Transparency & Redaction) – Syneos Life Sciences
Location: India-Asia Pacific – IND-Gurugram-DLF Downtown, India
Job ID: 23006852-IND501
Company Background:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage clinical, medical affairs, and commercial insights to address modern market realities. Our customer-centric approach places the patient at the center of everything we do. With a global presence and a commitment to simplifying and streamlining work processes, we strive to create a collaborative environment that enables us to make a difference in people’s lives.
Job Description:
Syneos Health is currently seeking a Medical Writer II with expertise in Clinical Trial Transparency & Redaction. As a medical writer, you will play a crucial role in ensuring the accuracy and compliance of clinical study documentation. Your responsibilities will include authoring and quality assurance of project activities, as well as supporting the preparation of disclosure documents for regulatory bodies. In addition, you will have the opportunity to contribute to internal and client-specific training and mentorship.
Responsibilities:
1. Authoring and Quality Assurance of Project Activities:
- Execute project-specific activities with high quality and in defined timelines according to standard processes and operating procedures
- Review, edit, and mark clinical study documents, patient narratives, clinical summaries, and other documents for regulatory submission
- Perform quality control checks on documents prepared by colleagues against pre-specified checklists
- Conduct detailed analyses on processes and their outputs
2. Additional Activities:
- Complete internal and client-specific training
- Assist in mentoring and training of team members as per project requirements
Qualifications:
- Educational qualifications: A minimum of a scientific graduate degree in life sciences.
- Good knowledge of regulatory requirements or guidance pertinent to the service line.
- Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines. Clear written and verbal communication skills
- Good knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
- Person should understand & comprehend protocol and clinical study report from disclosure perspective.
- Good understanding of clinical trial disclosure fundamental
- Core competencies for this role include ability to demonstrate:
o Analytical capabilities with scientific and clinical data
o Professional working environment
o Ownership of the work allocated
o Commitment to highest quality outputs, including high attention to detail
o Enthusiasm and pro-activity
o Effective team working
- Ability to build rapport/ relationships with project-specific client colleague
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