Medical Writer Intern Resume Amesbury, MA - Hire IT People

SUMMARY

3 years’ experience in upstream (cell culture) cGMP biologics Quality Documentation and Manufacturing, including preparing SOPs, Master Batch Records, Manufacturing Instruction (MI), Change Controls, Deviations, Validations, Out of Specifications (OOS) and CAPAs
Comprehension of FDA and EMA guidelines, as well as ICH guidelines, including cGMP requirements and quality practices, such as 21CFR210, 21CFR211, 21CFR820, etc.
Expertise in Quality requirements, such as change controls, CAPAs, deviations, specifications, audits, inspections, etc.
Experience of preparing cGMP documentations, such as SOPs, Batch Records, and Manufacturing Instruction (MI)
Good command of upstream mammalian cell culture cGMP production activities, as well as process development and improvement
Experience of upstream mammalian culture process technology transfer, scale - up and scale-down activities
Good understanding of FDA and EMA regulations and guidance, as well as ICH guidelines
Comprehension of drugs, biologics, and medical devices regulatory submission pathways and requirements, such as IND, NDA, BLA, ANDA, IDE, 510(k) premarket notifications, PMA, annual reports, supplements, amendments and CE marking application
Comprehension of Quality system, such as 21CFR210, 21CFR211, 21CFR820, ISO 13485 Quality Management Systems, etc.
Experience of medical writing in support of CE marking submission
Expertise in literature searches and reviews, ae well as EndNote software
Comprehension of GCP requirements, such as Informed Consent Form, Case Report Forms, protocol amendments, Form 3500A, Form 3454, Form 3455, etc.

TECHNICAL SKILLS

Software: MS Office (Excel, Word, and PowerPoint), Adobe and EndNote

Personal: Self-motivated, multi-tasking, detail-oriented, interpersonal, adaptable, exemplary analytical, and strong organizational abilities, as well as excellent written and verbal communication skills

PROFESSIONAL EXPERIENCE

Confidential, Amesbury, MA

Medical Writer Intern

Responsibilities:

Supported creation of Clinical Evaluation Reports (CERs) in compliance with Essential Requirements, and prepared materials for CE marking application.
Conducted comprehensive literature search on both post-market surveillance and research databases, such as Medical Device Reporting (MDR), Total Product Life Cycle (TPLC), Medical Device Recalls, Manufacturer and User Facility Device Experience (MAUDE), PubMed, EMBASE and Cochrane database.
Prepared literature search protocol and report based on EU guidance: MEDDEV 2.7/1 Rev. 4.

Confidential, Boston, MA

Regulatory Affairs Experiential Network Project

Responsibilities:

Assisted with developing global regulatory strategy for an innovative medical device.
Helped with searching and interpreting applicable regulations and guidance, such as the FDA regulatory requirements for exporting investigational devices.
Assisted with classifying a developing medical device based on the FDA regulations and EU Medical Devices Directive (MDD), and helped with interpreting the regulatory requirements in support of 510(k) and CE marking application.

Confidential

Research (Quality Documentation) Associate

Responsibilities:

Revised and updated Standard Operating Procedures (SOPs), Master Batch Records and Manufacturing Instruction (MI) for upstream biologics production procedures in compliance with cGMP requirements.
Conducted deviation and root cause analysis, as well as drafted CAPA documentation.
Conducted cGMP upstream production activities, including mammalian cell bank establishment, cell expansion to 150L bioreactors, cell growth and metabolite trends monitor, as well as cell culture harvest and clarification steps.
Performed medium and feeding optimization studies for cell culture process in shake flasks and 2L scale bioreactors. Successfully improved a monoclonal antibody productivity by 50% and applied toward 150L scale production for phase III clinical trials.
Executed global Industrial Cooperation Program with GE Healthcare. Successfully developed a seed expansion step of 12-fold greater cell density by perfusion culture using WAVE bioreactor system.

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Medical Writer Intern Resume

Amesbury, MA

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