プロフィール詳細

プロジェクトを作成

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Dr. Nadeem A.に依頼

Germany

Cell and Molecular Biologist | MBA in Medical devices and Healthcare Management | Certified in Regulatory Affairs - GxP

プロフィール概要

• Cell biologist with seven years of academic scientific writing experience • MBA candidate in Medical Devices and Healthcare Management with the goal of supporting life sciences in RO I Biotech I • Medtech and Pharma industry • Certified in GxP regulations (GMP | GCP| GLP| GPvP) and others Expert in: • Scientific Writing (creating, editing, proof-reading) for Medical research journals • Writing Conceptual and procedural guides for equipment and techniques • Presentations and communications in a cross-functional team Merits of relevance: • Published data in four peer-reviewed scientific journals • Established a network of scientists and researchers in Europe and worldwide • 10+ Scientific appearances in national and international symposia and Conferences • 5 poster presentations and a conference talk in International Symposia and Scientific meetings I can help you with: • Regulatory writing documents, needed from the manufacturing of your medical product (GMP, QMS, Auditing, CE marketing) to launching your products to the European market to their labeling. • Scientific writing, including study reports, abstracts, scientific publications, posters • Proofreading a scientific paper or wirting 💡 Clear, concise, and professional writing tailored for your audience and their level of understanding!

専門分野

• ★ European Medical Device Regulation (MDR)
• ★ EU In vitro Diagnostic Regulation (IVDR) Compliance
• ★ Medical Device Regulatory Writing
• ☆ Microbiology
• ☆ Biostatistics
• ☆ Biochemistry
• ☆ Immunoassay
• ☆ Biochemical Assays
• ☆ Apoptosis
• ☆ Enzyme Activity Assays
• ☆ Molecular Biology
• ☆ Biomarkers
• ☆ Genetics
• ☆ Microarrays
• ☆ Molecular Evolution
• ☆ Chromatin
• ☆ Epigenetics
• ☆ PCR
• ☆ Molecular Cloning
• ☆ DNA Sequencing
• ☆ Protein Sequencing
• ☆ Gene Expression Analysis
• ☆ Mutagenesis
• ☆ Recombinant DNA
• ☆ RNA Synthesis
• ☆ DNA/Gene Synthesis
• ☆ Plasmid DNA
• ☆ Cell Biology
• ☆ Cell-Based Assays
• ☆ Cytochemistry
• ☆ Cytogenetics
• ☆ Cell Signaling Pathways
• ☆ Gene Regulation
• ☆ Stem Cell Research
• ☆ Data Collection
• ☆ Clinical Microbiology
• ☆ Cell Culture
• ☆ Cell Banking
• ☆ Knowledge Management
• ☆ Taxonomy/Classification
• ☆ Blotting
• ☆ Immunohistochemistry
• ☆ Cytometry
• ☆ Cell Aging
• ☆ Information Retrieval
• ☆ Information & Knowledge Management
• ☆ Medical Devices
• ☆ Post-Market Surveillance
• ☆ Medical Device Development
• ☆ Biocompatibility Testing
• ☆ Medical Device Manufacturing
• ☆ Medical Device Validation
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ In vitro Diagnostics
• ☆ In vitro Diagnostic Validation
• ☆ Medical Equipment & Supplies
• ☆ Regulatory Writing
• ☆ Medical Device Literature Reviews
• ☆ Premarket Notification/510(k) Submission
• ☆ PreMarket Approval (PMA) Applications

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, General Proofreading & Editing

Research Market Research, User Research, Fact Checking, Gap Analysis, Scientific and Technical Research

Consulting Business Strategy Consulting, Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Product Development Product Evaluation, Quality Assurance & Control (QA/QC), Product Compliance , Concept Development

職務経験

EDUCATOR IN STEM SUBJECTS FOR A AND O-LEVELS

International IT College of Sweden| Sweden

8月 2015 - 8月 2022

ASSISTANT PROFESSOR

Lahore University of Management Sciences (LUMS)| Pakistan

3月 2014 - 12月 2014

JUNIOR RESEARCHER (PhD CANDIDATE)

Unit of Toxicology, IMM, Karolinska Institute| Sweden

1月 2009 - 2月 2013

Associate Research Fellow

Ludwig Cancer Institute| Uppsala University | Sweden

3月 2008 - 12月 2008

Research Officer/Senior Research Officer

University of Punjab Lahore

6月 2006 - 2月 2008

学歴

MBA in Medical devices and Healthcare Management

International Business School Tuttlingen (IBST)| Germany

8月 2022 - 現在

The London School of Economics and Political Science (LSE)

MBA Essentials

9月 2022 - 12月 2022

PhD

Karolinska Institute| Sweden

1月 2013 - 2月 2019

認定資格

• Good Clinical Practice as laid down in the International Conference on Harmonisation Guidelines

  Whitehall Training

  https://drive.google.com/drive/u/1/folders/1ZzceOUV6ryF4-djkfV3g6XSGO3Y5BJPx

  10月 2022 - 現在

• Good Manufacturing Practice

  Whitehall Training

  https://drive.google.com/drive/u/1/folders/1ZzceOUV6ryF4-djkfV3g6XSGO3Y5BJPx

  10月 2022 - 現在

• GLP - Good Laboratory Practice

  Whitehall Training

  https://drive.google.com/drive/u/1/folders/1ZzceOUV6ryF4-djkfV3g6XSGO3Y5BJPx

  10月 2022 - 現在

• Medical Device Safety and Vigilance

  Whitehall Training

  https://drive.google.com/drive/u/1/folders/1ZzceOUV6ryF4-djkfV3g6XSGO3Y5BJPx

  10月 2022 - 現在

• Regulatory aspects of Pharmacovigliance

  Uppsala Monitoring Centre

  https://drive.google.com/file/d/1ETed05jRQz0oJ9KLSdF9eIV4hU4AjHHD/view

  10月 2022 - 現在

• GCLP - Good Clinical Laboratory Practice

  Whitehall Training

  https://drive.google.com/drive/u/1/folders/1ZzceOUV6ryF4-djkfV3g6XSGO3Y5BJPx

  10月 2022 - 現在

• Risk reduction of Chemicals

  Swedish Chemicals Agency

  https://drive.google.com/file/d/1tKDWcqD1MEaLqbIm51AuznnI5S3q70Wq/view

  9月 2022 - 現在

• Essential of Pharmacovigilance communications

  Uppsala Monitoring Centre

  https://drive.google.com/file/d/1W8yoiozQQTwbG9DF0rRhi_RrJ_UbRdZF/view

  9月 2022 - 現在

• Learning HubSpot CRM

  LinkedIn

  https://www.linkedin.com/learning/certificates/60aebbd6ec9a9d8431bcb26b64315e6d9f891ef3392b619318a3e1bdff0308af

  4月 2022 - 現在