Senior Documentation Lead
Healthcare & Life Sciences · BioTech & Pharmaceuticals · Clinical Research
In short
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.
Responsibilities
- 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.
Requirements
- 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.
Desired Qualifications
- Advanced degree in life sciences, pharmacy, or medicine (e.g., PharmD, PhD, or MSc).
Benefits
- 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
Company
HCLTech
Job Posted
1 month ago
Employment Type
Full Time
WorkMode
On Site
Experience Level
Senior
Locations
Hyderabad, India
Qualification
Doctoral, Master
Applicants
Be an early applicant