Senior Documentation Lead

Job Summary

To support junior/senior writers, address technical queries, and propose appropriate solutions for issues.

Key Responsibilities

1. To support junior/senior writers, plan document plan-task estimation, and monitor project status.
2. To address technical queries, monitor compliance/trainings, conduct product competency training, and ensure timely knowledge transfer.
3. To research and propose solutions, ensure timely updates are provided to clients, and monitor and flag issues that require resolution.
4. To be the point of contact for all escalations in the team and execute mitigation steps for resolution.
5. To discuss team level improvements/KRAs with managers, provide feedback to team members, and suggest improvement plans for team.

Skill Requirements

• Develop high quality clinical documents ensuring scientific excellence. The development process includes writing, interpreting and summarizing clinical and non-clinical data, compiling information and ensuring delivery within timelines. Clinical documents may include protocols, investigator brochures, clinical study reports, integrated reports, clinical sections of core technical documents/drug applications/briefing documents per regulations.

• Ensure compliance of clinical documents with national and international regulatory requirements and guidelines

• Work closely with cross-functional team members and serve as MW representative at study team meetings.

• Prepare document timelines

Other Requirements

• Advanced degree in life sciences, pharmacy, or medicine (e.g., PharmD, PhD, or MSc).

• 5+ years of experience in medical writing in the pharmaceutical or clinical research industry

• Skills: Exceptional written and verbal communication, high attention to detail, and proficiency in medical terminology and statistical interpretation.

• Tools: Familiarity with style guides (e.g., AMA) and reference management software (e.g., End Note)

• ICH GCP and pertinent regulations