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MAL LAMML
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MAL LAM

@mallam

I manage eTMF and regulatory document lifecycles, running QC/completeness checks to keep studies inspection-ready.

United States
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What I'm looking for

I’m looking to keep supporting regulated pharma/medical device teams with eTMF structure, document QC/completeness checks, TMF readiness, and regulatory submission support—so studies stay organized, auditable, and on schedule.

I’ve supported clinical studies across the document lifecycle at ProClinical–AbbVie Pharma, building ETMF structure in Veeva Vault and defining the Expected Doc List so teams stay on track for GDP, ALCOA, and TMF inspection readiness.

In my QC review work, I maintain documentation in ClinOps ETMF and internal filing systems, file proof of QC activities in Veeva Vault, and generate Veeva Vault metric reports for site, country, and study-level oversight. I also lead TMF meetings to make sure ETMF responsibilities are clearly defined and executed.

More recently, I’ve handled regulatory review workflows on projects like Apidel–Epiq Global by migrating data into QMARS, capturing beneficiary/provider details, assigning peer reviewers, uploading medical records, and moving cases through completion workflows.

Experience

Work history, roles, and key accomplishments

MH

Review Assistant – Regulatory

Metasystem-Acentra Health

Feb 2026 - Apr 2026 (2 months)

Managed the front end of the medical review lifecycle by migrating data from ANG Altrezzo to QMARS, capturing beneficiary and provider data, and moving cases through workflows.

AI

Data Entry

Apidel-Xfinity Internet

Jun 2025 - Dec 2025 (6 months)

Executed agency mappings for stakeholder reporting, extracted Tableau reports, and processed change requests in D365 and Boss mapping tool.

PP

Clinical Document Control/Data Entry

Proclinical - AbbVie Pharma

Oct 2021 - Dec 2024 (3 years 2 months)

Supported document lifecycle for clinical studies in Veeva Vault, performed QC checks, generated metric reports, and facilitated TMF meetings.

JP

Document Control/Data Entry

Joule Staffing-Verrice Pharma

Oct 2020 - May 2021 (7 months)

Migrated eTMF study files from CRO storage to ZenQMS, prepared clinical documents for SharePoint, and performed QC review for ALCOA and GDP.

IP

Document Management/Data Entry

Intepros Staffing-West Pharma

Jul 2019 - Oct 2020 (1 year 3 months)

Managed notebook requests, entered purchase orders in CRM and LIMS, performed batch record review, and updated employee records in SAP.

AP

Document Management/Data Entry

Advanced Clinical Staffing-CSL Behring Pharma

Jun 2016 - May 2019 (2 years 11 months)

Supported clinical studies by establishing eTMF structure, performing QC review, and managing SharePoint folders for document organization.

AP

Document Management/Data Entry

Apex Staffing-Covance Pharma

Jan 2015 - May 2016 (1 year 4 months)

Performed second-pass data entry of clinical documents and issued reports with metrics to management.

VM

Regulatory

Volt Assoc – Draeger Medical

Jan 2013 - Dec 2014 (1 year 11 months)

Supported regulatory activities including document management and submission preparation.

MP

Regulatory

Medfocus Staffin – GSK Pharma

May 2010 - Dec 2012 (2 years 7 months)

Built and published submissions in eCTD software, reviewed documents for FDA guidelines, and maintained submission trackers.

BL

Regulatory

Barr Labs

Aug 2005 - Mar 2010 (4 years 7 months)

Built and published submissions in eCTD software, reviewed documents for FDA guidelines, and maintained submission trackers.

AM

Customer Service/Claims

Amerihealth

Jan 2001 - Jun 2005 (4 years 5 months)

Received member calls regarding health coverage, investigated claim denials, and processed medical claims.

HP

Lab Tech

Hospice Pharmacia

Dec 1995 - Dec 2000 (5 years)

Received prescription orders, worked in lab production to prepare medications, and managed inventory.

Education

Degrees, certifications, and relevant coursework

AS

Audenried High School

High School Diploma, General Education

High school diploma received.

Tech stack

Software and tools used professionally

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