Medical Writer II

This is a fully remote position, open to applicants in India.

📋 Description

• Responsible for medical writing, including PSURs, PBRERs, PADERs, ACOs, DSURs, and RMPs.

• Quality control and review of all documentation produced by the operations team as necessary.

• Assisting project managers in scheduling the aggregate reports they oversee.

• Collaborating with the Quality, Compliance, and Training Manager to identify improvement areas and address them through training, clarifying changes to SOPs, OGs, and templates.

• Completing quality documentation for aggregate reports.

• Participating in kick-off meetings with new clients as needed.

• Attending audits and inspections as required.

• Delivering training on aggregate reporting.

⛳️ Requirements

• A degree in Medicine, Pharmacy, or Life Sciences (Masters or PhD preferred).

• Significant prior experience in Pharmacovigilance, including case processing, signal detection, or risk management, preferably within a CRO setting.

• Capability to handle multiple diverse tasks and effectively prioritize workload while maintaining attention to detail.

• Skill in training and mentoring Associate Medical Writers.

• Must be a strong collaborative team member.

• Proficiency in English; knowledge of an additional language is advantageous.

🏝️ Benefits

• Opportunities for training and career development within the organization.

• Strong focus on personal and professional advancement.

• A friendly and supportive working environment.

• Chance to collaborate with colleagues from around the globe, with English as the primary language of communication.