The Job

Senior Documentation Lead

Healthcare & Life Sciences · BioTech & Pharmaceuticals · Clinical Research

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I korthet

HCLTech is seeking a Senior Documentation Lead in Hyderabad, Telangana, to guide junior writers, manage document plans, and address technical queries. This role involves developing high-quality clinical documents, ensuring compliance with regulations, and collaborating with cross-functional teams.

Ansvarsområden

  • Support junior/senior writers, plan document tasks, and estimate timelines.
  • Monitor project status and ensure timely delivery.
  • Address technical queries and ensure timely knowledge transfer.
  • Research and propose solutions for issues.
  • Ensure timely updates are provided to clients.
  • Monitor and flag issues that require resolution.
  • Act as the point of contact for team escalations and execute mitigation steps.
  • Discuss team improvements and KRAs with managers.
  • Provide feedback to team members and suggest improvement plans.
  • Develop high quality clinical documents ensuring scientific excellence.
  • Interpret and summarize clinical and non-clinical data.
  • Compile information and ensure delivery within timelines.
  • Work closely with cross-functional team members and serve as MW representative at study team meetings.
  • Prepare document timelines.

Krav

  • 5+ years of experience in medical writing in the pharmaceutical or clinical research industry.
  • Exceptional written and verbal communication skills.
  • High attention to detail.
  • Proficiency in medical terminology and statistical interpretation.
  • Familiarity with style guides (e.g., AMA).
  • Familiarity with reference management software (e.g., EndNote).
  • Knowledge of ICH GCP and pertinent regulations.

Önskade kvalifikationer

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

Förmåner

  • Industry-benchmarked compensation
  • Best-in-class healthcare benefits
  • Personal time off
  • Maternity and paternity benefits
  • Access to skills / higher education programs/resources
  • Discounts on products and services via Benefit Box
  • Participate in CSR programs and live life with a purpose
  • Opportunities to grow and advance your career
#documentation#lead#medical writing#pharmaceutical#clinical research
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Företag

HCLTech

Publicerade jobb

för 1 månad sedan

Anställningstyp

Heltid

Arbetsform

På plats

Erfarenhetsnivå

Senior

Platser

Hyderabad, India

Kvalifikation

Doktorand, Masterexamen

Sökande

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