Namita Gowtham
Associate Medical Manager
Bengaluru
Summary
Medical writing expert with a proven track record of simplifying complex medical research for diverse audiences, including healthcare professionals, patients, and regulatory authorities. NIPER graduate with a strong scientific foundation and consistently adaptive approach to evolving industry standards and client needs. Recognized for collaborative teamwork, reliability, and delivering results in fast-paced, deadline-driven environments. Proficient in scientific writing, literature review, health literacy-focused communication, and regulatory documentation with meticulous attention to detail and commitment to quality.
Overview
8
8
years of professional experience
Work History
Associate Medical Manager
Pfizer India Pvt. Ltd.
04.2022 - Current
- Optimized patient and prescriber content using standard health literacy best practices.
- Delivered quality patient information that is easier to read, shareable with their healthcare providers.
- Reviewed and provided comments on the content to help the team improve their health literacy standards of their materials.
- Created documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products. Some examples of such documents include briefing documents to support meetings with regulatory agencies such as Health Hazard Assessments and Reg 21 Medical Evaluation Committee slide decks for drug withdrawals.
- Established efficient document tracking systems to monitor progress against project timelines and deliverables.
- Provided guidance on scientific content to team members while editing their work to ensure accuracy, clarity, and consistency throughout the document development process.
- Implemented innovative approaches to streamline document development processes, resulting in reduced turnaround times and increased overall team productivity.
- Collaborated with clinicians, clinical scientists and biostatisticians to interpret study results and accurately reflect in relevant documents.
- Adapted writing style to suit primary and secondary care physicians, specialists, nurses, patients and other stakeholders.
Associate Scientific Writer
Indegene Pvt. Ltd.
01.2021 - 04.2022
- Strong flair in developing content for various deliverables by meeting quality requirements as per client satisfaction metrics.
- Possess excellent communications skills to manage client interactions
- Capable of developing and reviewing the scientific content for promotional literature and medico-marketing solutions such as promotional emails, patient/physician brochures, newsletters, product/drug monographs, digital and print channels, visual aids, websites, social medial channels etc.
- Possess the skill for developing innovative scientific content for physicians, pharmacists and patients on medicinal products, diagnostic devices, disease management guidelines, by leveraging their in-depth understanding of medical/scientific content.
- Have a working knowledge on digital campaigns, creating content strategy and defining multi-channel tactics for these campaigns.
Officer-Medical Writing
Lotus Labs Pvt. Ltd.
07.2017 - 01.2021
- Trained in ICH-GCP, FDA-GCP and ICH-GLP through CITI program.
- Promptly delivered Module 5 (m5) for USFDA studies and eCTD for various regulatory bodies such as EMA, Health Canada, ANVISA, ASEAN, relevant authorities of South Africa, Japan and China.
- Team member for numerous priority submissions and assigned integral parts of study.
- Single handedly executed fast track projects successfully, adhering to strict submission timelines.
- Conducted training sessions for pivotal studies and additional documents required by various regulatory authorities such as OGD, CSBE, BTIF, Module 2.7.1.
- A sound understanding of functioning of Clinical Research Organization.
- Medical writing, being the end-user department, involving interactions with various cross functional departments for data related queries from the sponsors/regulatory authorities, thereby developing strong communication skills.
Education
Master of Science - Pharmaceutics
National Institute of Pharmaceutical Research And Education
Lucknow, India06-2017
Bachelor of Pharmacy - Pharmacy
PES College of Pharmacy
Bengaluru, India05-2015
Skills
- Medical and Scientific Writing
- Health Literacy and Patient-Centered Communication
- Regulatory Submissions and Compliance
- Content Strategy and Digital Campaigns
- Collaboration and Cross-Functional Communication
- Project Management and Process Optimization
- Content Review and Quality Assurance
- Stakeholder-Centric Writing
- Training and Mentorship
- Data Interpretation and Analysis
Timeline
Associate Medical Manager
Pfizer India Pvt. Ltd.
04.2022 - Current
Associate Scientific Writer
Indegene Pvt. Ltd.
01.2021 - 04.2022
Officer-Medical Writing
Lotus Labs Pvt. Ltd.
07.2017 - 01.2021
Master of Science - Pharmaceutics
National Institute of Pharmaceutical Research And Education
Bachelor of Pharmacy - Pharmacy
PES College of Pharmacy
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