Syneos Health is hiring for the Medical Writer II position in India, with remote and hybrid work locations available. The role involves preparing and reviewing clinical and regulatory documents, including clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), and informed consent forms (ICFs).
Candidates with 3–5 years of relevant experience in medical, scientific, or technical writing and experience in the biopharmaceutical, medical device, or contract research organization (CRO) industry can apply. Experience with pharmacokinetic/pharmacodynamic (PK/PD) studies and Phase II/Phase III clinical trials is also relevant to this opportunity.
Syneos Health Medical Writer II Job Details
| Job Detail | Information |
|---|---|
| Company | Syneos Health |
| Job Title | Medical Writer II |
| Job Requisition ID | 25112489 |
| Job Location | India |
| Work Mode | Remote (Pre-Approved) / Hyderabad-Hybrid |
| Job Type | Full-Time |
| Experience | 3–5 years of relevant experience |
| Industry | Biopharmaceutical, Medical Device, or CRO |
| Application Mode | Online |
Position
Medical Writer II
The selected candidate will manage medical writing deliverables for clinical development and regulatory submissions, ensuring scientific accuracy, document quality, and compliance with applicable regulatory guidelines.
Job Responsibilities
Key responsibilities of the Medical Writer II position at Syneos Health include:
- Prepare clinical study protocols, protocol amendments, clinical study reports, patient narratives, and investigator brochures.
- Develop informed consent forms, periodic safety update reports, annual reports, and plain language summaries.
- Prepare regulatory submission documents, including IND submissions, NDA and eCTD submissions, integrated summary reports, and clinical development plans.
- Write scientific manuscripts, abstracts, posters, and presentations for scientific meetings.
- Coordinate medical writing activities across departments and manage client comments with minimal supervision.
- Conduct quality and editorial reviews to ensure scientific accuracy, clarity, consistency, and appropriate formatting.
- Review statistical analysis plans and table, figure, and listing specifications.
- Conduct clinical literature searches while complying with copyright requirements.
- Collaborate with data management, biostatistics, regulatory affairs, medical affairs, clients, and internal teams.
- Provide technical guidance, training, and mentoring to less experienced medical writers.
- Follow applicable ICH guidelines, company standard operating procedures, client standards, and approved document templates.
- Monitor project timelines and budgeted hours and communicate progress or issues to medical writing leadership.
Eligibility and Qualifications
Candidates applying for the Syneos Health Medical Writer II job should meet the following requirements:
- Experience: 3–5 years of relevant experience in science, technical, or medical writing.
- Industry Experience: Experience in the biopharmaceutical, medical device, or contract research organization industry.
- Medical Writing Experience: Experience preparing relevant clinical and regulatory documents.
- Clinical Study Experience: Experience working with PK/PD studies, CSRs, IBs, ICFs, and clinical study protocols.
- Clinical Trial Phases: Experience with Phase II and Phase III studies, with readiness to work on early-phase studies.
- Regulatory Knowledge: Strong understanding of FDA and ICH regulations, other applicable regulatory guidelines, and/or good publication practices.
Required Skills
Applicants should have the following skills and knowledge:
- Strong scientific and medical writing abilities.
- Excellent English grammar and clear communication skills.
- Familiarity with the AMA Manual of Style.
- Knowledge of clinical and regulatory document preparation.
- Understanding of ICH E3 guidelines and applicable regulatory standards.
- Scientific content review, proofreading, and editorial quality control.
- Ability to coordinate cross-functional activities and resolve document review comments.
- Strong attention to scientific accuracy, consistency, formatting, and deadlines.
Work Location and Application Details
Syneos Health lists the following work locations for this position:
- IND-Remote: Remote work, subject to pre-approval.
- IND-Hyderabad-Hybrid: Hybrid work location in Hyderabad, India.