# Afsha Majid

Afsha Majid is a remote worker on Himalayas, Medical Writer at PPD, Thermo Fisher Scientific, based in India.

Source: https://himalayas.app/@afshamajid

```text
Medical Writer at PPD, Thermo Fisher Scientific, drafting ICH-GCP-compliant consent forms and regulatory documents across oncology and rare diseases.
```

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| Salary expectations | 83k+ USD |
| Job categories | Medical Writer, Research Analyst |
| Skills | Regulatory Medical Writing, ICH GCP, ICH E3 Clinical Study Report Awareness, ICH E6, ICH E8 (R1), Informed Consent Forms, Clinical Study Report (CSR), Investigator Brochures, Protocol Synopses, NDA And (E)CTD Submissions, Regulatory Requirements, Oncology, Rare Diseases, Immunology |

## What I'm looking for

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I’m looking for a medical writing role where I can leverage my 5+ years of experience in clinical and regulatory writing while contributing to patient-centric communication. I’m particularly interested in opportunities involving clinical development, regulatory submissions, informed consent documents, and lay/patient-focused materials.
```

## About

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At PPD, Thermo Fisher Scientific, I draft, review, and finalize Informed Consent Forms that comply with ICH-GCP guidelines. My work covers oncology, rare diseases, and immunology.

I interpret complex scientific and clinical data for regulatory documents aligned with FDA and EMA requirements. I also support protocol synopses and amendments for Phase II–III clinical trials.

At DAVA Oncology LP, I contributed to protocol synopses for Phase I–III oncology studies and conducted statistical analyses using MS Excel. I also prepared patient gap analysis reports on unmet needs in oncology treatment pathways.

My research on adipokines in Non-Hodgkin’s Lymphoma contributed to a peer-reviewed publication in the Journal of Neuroimmunology. I hold a Master’s in Clinical Research from Jamia Hamdard University.
```

## Experience

### Medical Writer (current)

PPD, Thermo Fisher Scientific. Apr 2021 - Present

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Draft, review, and finalize ICH-GCP-compliant Informed Consent Forms across therapeutic areas including oncology and rare diseases. Collaborate with cross-functional teams to ensure timely delivery of high-quality regulatory documents.
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Skills: Regulatory-Medical-Writing, ICH-GCP, Informed-Consent-Forms, Clinical-Study-Report-(CSR), Investigator-Brochures, Protocol-Synopses, Oncology, Rare-Diseases, FDA, EMA, eCTD, MedDRA, Microsoft-Office, Project-Management

### Research Analyst

DAVA Oncology LP. Sep 2020 - Mar 2021

```text
Contributed to authoring protocol synopses for Phase I-III oncology clinical studies, ensuring alignment with ICH and FDA guidance. Conducted statistical analyses and prepared patient gap analysis reports.
```

Skills: Protocol-Synopses, Oncology, ICH, FDA, Excel, Statistical-Analysis, Data-Presentation, Patient-Gap-Analysis, Investigator-Meetings

## Education

### Jamia Hamdard University

Master's, Clinical Research. 2018 - 2020. Grade: 8.8/10

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Master's in Clinical Research with a CGPA of 8.8/10. Thesis on blood biomarkers as predictors of COVID-19 severity and mortality.
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### University of Delhi

Bachelor's (Honours), Zoology. 2015 - 2018. Grade: 8.6/10

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Bachelor's in Zoology (Honours) with a CGPA of 8.6/10.
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### Coursera

Certification, Systematic Reviews & Meta-Analysis

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Completed certification in Systematic Reviews & Meta-Analysis.
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### Coursera

Certification, Writing in the Sciences

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Completed certification in Writing in the Sciences from Stanford University.
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### Coursera

Certification, Epidemiology & Public Health

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Completed certification in Epidemiology & Public Health.
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### Coursera

Certification, Clinical Trial Design

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Completed certification in Clinical Trial Design.
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## Tech stack

- Microsoft Excel
- Microsoft Word
- Microsoft Outlook

To contact Afsha, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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