Jobs

Interviews
Job Alerts
Tools

Upskill and Grow with AI

Mock Interview Practice interviews in realistic simulations

Coding Practice Improve your coding skills with challenges

Certification Earn certifications to validate your skills

AI Learning Get trained with AI expert sessions

Career Path AI insights for smarter career decisions

AI Job Match Score AI-Powered Job Match Against Your Resume and Optimize Your Resume

Career Tools and Resources

Resume Builder Build Professional Resume with Ease

ATS Friendliness Check Check Resume Friendliness for Applicant Tracking Systems

Auto Apply Apply to hundreds of jobs on any platform effortlessly

Co-Pilot (Chrome Extension) Your AI Assistant for Seamless Browsing Efficiency

Interview Questions Streamline interviews with ready-to-use questions

Salaries Discover market-driven salary insights across skillsets and geographies

Companies Explore leading companies actively hiring talent
For Employers

Home
>
Jobs in pune
>
Axtria
>
Manager-Clinical Solutions CoE

Manager-Clinical Solutions CoE

Axtria

5 - 10 years

20 - 25 Lacs

pune

Posted:5 days ago| Platform:

Apply

Skills Required

sap artificial intelligence sdlc solution management ml project management python natural language processing sme change request management machine learning problem management change management data science itsm incident management sap basis itil

Work Mode

Work from Office

Job Type

Full Time

Job Description

Client discovery, scoping, and requirements (business-side)

Lead requirements elicitation with client Medical Writing/Regulatory teams for CSR authoring (template standards, TA nuances, target sections, review cadence, acceptance criteria, quality bars).

Translate business goals (timelines, submission strategy, risk tolerance, review workflows) into clear deliverables and negotiate scope, timelines, and costs; manage change requests and approvals.

Define “done” for each CSR section (e.g., Safety Evaluation, Efficacy) including scientific tone, numerical consistency, and ICH E3 alignment; maintain a living Requirements & Assumptions log

Translation to technical work (internal hand-off)

Convert business requirements into technical briefs for the GenAI Engineer (priority TLFs, required tables/figures, prompt constraints, style rules, traceability links to sources)

Specify validation frameworks for GenAI outputs (accuracy, completeness, faithfulness, numerical parity with TLFs) and co own evaluation rubrics with engineering.

Own the backlog for Rapid CSR features during engagements (as Business PO), prioritize bugs/iterations based on medical writing impact and regulatory readiness

Run structured review cycles(internal QC client SME review stat review) and close comments to final

Required Skills and Qualification

Advanced degree in Life Sciences, Pharmacy, or related field.

Proven track record (8–12 years) in CSR authoring and regulatory writing.

Strong understanding of clinical trial processes and regulatory guidelines.

Working knowledge of GenAI/LLMs and AI/ML SDLC (prompts, evaluation, HIL review, versioning).

Comfort with clinical data sources (TLFs, SAP, protocol, narratives) and numerical consistency checks

Excellent planning, negotiation, and stakeholder management skills.

Soft
Skills:

Work closely with cross-functional teams, including clinical data engineers, clinical data modelers, front end developers, QA/CSV specialists, clinical SMEs, project managers, and cloud/infrastructure professionals, to understand project requirements and deliver high-quality solutions.

Maintain thorough documentation of methodologies, processes, and results of the models. Prepare and present detailed reports on assigned projects to stakeholders, including client and internal leadership illustrating the impact and effectiveness of data-driven strategies.

More Jobs at Axtria

Manager - R&D

Gurugram

15 - 20 yrs

INR 17 - 22 Lacs

Decision Science

Bengaluru

2 - 5 yrs

INR 10 - 15 Lacs

Senior Associate HEOR

Hyderabad

3 - 6 yrs

INR 10 - 15 Lacs

Associate- Decision Science

Bengaluru

2 - 4 yrs

INR 8 - 12 Lacs

Associate- Finance

Gurugram

2 - 5 yrs

INR 9 - 14 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Artificial Intelligence Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

Enhance Your Python Skills

Practice Python coding challenges to boost your skills

Start Practicing Python Now

Axtria

Software Development

Berkeley Heights NJ

Login to

Please Verify Your Phone or Email

Confirm Action

Manager-Clinical Solutions CoE