Senior Medical Writer (Clinical Evaluation)

POSITION DESCRIPTION

Job Title: Senior Medical Writer (Clinical Evaluation)

Location: Hyderabad

Exp: 5-12 years

Department: Clinical Medical Devices

· 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

Essential Qualifications Education:

· 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., EndNote)

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