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John Lee

Medical Communications Specialist / Medical Writing Expert

Professional Profile

 

  • Professional, goal-driven, dedicated, and trusted leader with over 20 years of team and project experience in the biotech/pharmaceutical industry

  • Expert in clinical/regulatory document writing, analysis, and interpretation of clinical, safety, and statistical data

  • Accomplished professional with a wide of range of experience across many companies in the biotech/pharma industry

  • Proven ability to work on multiple complex projects in detail, while also submitting projects in a timely manner

  • Energetic hard worker with excellent people skills and team values

  • Highly computer literate, with advanced trouble-shooting skills and ability to learn programs and systems with ease

  • A graduate of McGill University, with scientific laboratory experience and exposure to many disciplines

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WORK EXPERIENCE

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2017-present

SoCal Medical Communications

Owner/Freelance Medical Writer

Oncology, Hematology, Ophthalmology, Rare Diseases, Rheumatoid Arthritis

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  •     Management Role – establishment of Medical Writing groups for client: 
    o    provided medical writing group (3 writers and 1 QCer) to client to clean up CSRs in preparation for NDA submission, also          leading to providing CTD writing support for Modules 2.5, 2.7.3, and 2.7.4 in addition to other CTD modules
    o    transitioned client over to proper document management system allowing for collaborative authoring
    o    established QC group to account for gaps in process and to ensure quality of data reporting
    o    managed a group of 6 Medical Writers to handle client workload of CTD modules, CSRs, protocols and amendments, IBs,          regulatory response documents, briefing documents, clinicaltrials.gov, etc
    o    contributed to process changes allowing for efficient workflow and to provide checks and balances
    o    aided in transition to EU-CTR standards for protocols and IBs
    o    consulted for client looking to commence clinical trials in Korea and US
     

  • Updated Modules 2.5 and 2.7.3 with updated data for successful CHMP opinion paving the way for successful EU submission

  • Completed Phase 3 CSR utilizing lean authoring strategies for accelerated procedures and timelines in preparation of NDA filing

  • Finalized Phase 2/3 CSR and 120-day Safety Update with updated data, wrote regulatory pediatric and ethnic response documents, and 2 protocol amendments; working on briefing book and supporting protocol

  • Completed 2 Phase 1 CSRs

  • Finalized 10 Phase 1 oncology, 2 ophthalmology, 2 hemophilia protocols, as well as protocol amendments

  • Wrote 6 Investigator Brochure updates, and provided MW support for 4 Briefing Documents and 4 Meeting Responses

  • Wrote Safety Narratives for 2 NDA submissions

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2020-2021

Catalyst Biosciences, Inc

Principal Medical Writer

Hemophilia

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  • Wrote Phase 1 CSR

  • Drafted and finalized protocols and protocol amendments

  • Updated 2 Investigator Brochures

  • Entered result data and provided QC consultation on clinical trial registry work (clinicaltrials.gov)

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2019-2020

Karyopharm Therapeutics, Inc

Principal Medical Writer

Oncology

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  • Wrote and submitted Module 2.7.3 for NDA submission (PDUFA decision expected shortly)

  • Finalized other NDA modules for an additional NDA submission

  • Completed several protocols and amendments, including an emergency protocol for COVID-19

  • Initiated work on Phase 2 CSRs

  • Provided document and project management support for NDA Briefing Book and Briefing Meeting slide presentation

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2017-2019

Sanofi, US

Medical Writer IV

Oncology/Rare Diseases

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  • Spearheaded initiative for artificial intelligence writing of common CSR text

  • Finalized Phase 1 CSR for Multiple Myeloma as well as multi-indication IMPD and IB updates

  • Provided document and project management support for Type C Meeting Request, Briefing Document, and Pregnancy Lactation Labeling Rule Supporting Document

  • Wrote 3 AIFA Requests for Italian Medicines Agency

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2017-2017

Takeda Pharmaceuticals                       

Principal Medical Writer 

Oncology

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  • Successfully wrote and submitted Orphan Drug Applications for US and EU regulatory agencies

  • Finalized 2 protocol amendments

  • Led and coordinated writing activities for early development oncology compound

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2015-2017

Sanofi, US                                  

Medical Writer IV

Oncology

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  • Successfully submitted regulatory response leading to product approval in Canada (approved)

  • Completed quick turnaround for NDA submission (writing modules 2.7.4 and 5.2)

  • Finalized 2 Phase 2 CSRs

  • Provided support for work on successful sBLA Submission including writing support on Cumulative Analysis of Periodic Safety Reports and narratives, as well as QC support for 5.3.5.3 meta-analyses and literature reviews

  • Finalized Phase 3 CSR per post-marking requirements and Phase 2 CSR for Medical Affairs 

  • Coordinated completion of 2 IMPD updates (and 4 Benefit/Risk Assessments) in short amount of time in order to expedite initiation of Phase 2 trials

  • Took on leadership role in recently formed oncology team to complete documents in strict timeframes

 

2013-2015

Spectrum Pharmaceuticals, Inc.

Associate Director of Medical Writing and Publications

Oncology

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  • Completed work on 2 NDA Submissions in 1 year, both of which were FDA-Approved

  • Managed writing and preparation of approved 505(b)(2) NDA submission: reviewed clinical and nonclinical modules, oversaw writing of clinical and nonclinical modules by CRO, handled review process and incorporation of comments, organized over 600 journal articles in EndNote for use for NDA modules, and prepared documents for publishing – FDA accepted NDA in March 2015; FDA approval in March 2016

  • Provided key reviews of NDA Modules recently granted accelerated approval by FDA: Clinical Overview, Clinical Summary of Efficacy, Clinical Summary of Safety, Integrated Summary of Efficacy, and Integrated Summary of Safety for NDA submission (along with Modules 2.2, 2.7.6, 5.2) (FDA approval in July 2014)

  • Wrote 120-Day Safety Update leading to support of successful accelerated FDA approval of NDA – FDA sent official NDA approval in July 2014

  • Managed contract writers for clinical study protocols, clinical study reports, NDA clinical and nonclinical modules, and publications (manuscripts and abstracts)

  • Provided FDA Response Documents to support acceptance of several clinical study protocols

  • Edited manuscript related to NDA submission ensuring consistency and compliance with journal’s guidelines

  • Completed Style Guide for future in-house and outsourced Regulatory submissions

  • Strategized integration of EndNote reference library system into reference process

  • Created protocol template; tasked with creating the following: templates for CSRs and other Regulatory documents; SOPs and Work Instructions; process for document review 

 

2011-2013

Takeda Pharmaceuticals North America, Inc.       

Cardiovascular/Endocrinology/Metabolism

 

  • Completed writing of key Phase 1-3 CSRs (continuation of Associate Medical Writer roles below)

  • Wrote and managed annual updates to Investigator Brochures

  • Finalized work on Protocol Amendments as well as other key European submissions: IMPDs, PIPs, etc.

  • Responded to questions from FDA and other foreign regulatory authorities regarding previous submissions (eg., Briefing Documents, Asian, and European response documents – US, Canada, Brazil, Taiwan, Indonesia, Swiss, Korea)

  • Helped in creation of and provided QC support for 120 Day Safety Updates, and other CTD Module documents (Clinical Efficacy Summaries, Clinical Safety Summaries, Clinical Overview, and other documents related to IND submissions)

  • Collaborated and assisted in writing key sections of ISS, ISE, PPSR, PSUR, and 120 Day Safety Updates

 

2007-2011                                 

Takeda Pharmaceuticals North America, Inc.    

Cardiovascular/Endocrinology/Metabolism

 

  • Managed remote writers working on key Phase 3 studies in preparation of upcoming NDA

  • Completed writing of key cardiovascular Phase 1, Phase 2, and Phase 3 CSRs covering thousands of subjects including safety narratives of their SAEs, discontinuations, and fatal outcomes, which contributed to successful NDA Submission

  • Compiled study data for several module 5.2/2.7.6 Tabular Listing of Clinical Studies in support of IND and NDA Submissions

  • Managed the writing, review, and finalization of Clinical Study Reports for major CTD Submissions

  • Composed and oversaw completion of abbreviated CSRs for major CTD Submission

  • Oversaw completion of eCTD components by managing editors and QC group

  • Organized and led CSR and TLG review meetings with several functional areas: Pharmacovigilance/Safety, Clinical Operations, Clinical Science, Clinical Supplies, Regulatory (US and Europe), Data Management, and Statistics

  • Interacted with all functional areas (see above) serving as Medical Writing liaison in order to incorporate all team comments into 1st and 2nd drafts, as well as Final CSR

  • Represented Medical Writing at Compound Team CSR meetings

  • Wrote and coordinated CSR amendments for completion of CTD Submissions

  • Reviewed and corrected more than 500 Subject Narratives accompanying CSRs

  • Provided and maintained project management timelines and details for all CSR and CSR amendment schedules

  • Served as Regulatory Writer in revising Takeda’s protocol information template for use with www.clinicaltrials.gov as well as submitting 8 entries to www.clinicaltrials.gov

 

2007

Takeda Pharmaceuticals North America, Inc. 

Medical Editor 

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  • Maintained and updated several Medical Writing documents for major CTD Submission – 5.2 List of Clinical Studies, Master List of References, and Master List of Abbreviations

  • Provided Quality Control and Quality Assurance specifically in regards to data and content accuracy for Medical Writing documents including clinical study reports for both Actos and Rozerem, Takeda’s blockbuster drugs

  • Edited data and content of protocols, clinical study reports, patient narratives, investigator’s brochures, IND and NDA annual reports, briefing documents and IND and NDA submissions

  • Ensured compliance with Takeda’s document templates and style usage guidelines

 

2005-2007

Astellas Pharma, U.S.

Quality Assurance Analyst

 

  • Successfully reviewed and submitted several NDAs and INDs, including the Prograf MR NDA to the FDA at the end of 2005 and the Mycamine NDA in 2006 and Vaprisol in December 2005. Prograf MR is a modified release formulation of Astellas’ flagship drug, used as an immunosuppressant in anti-rejection therapy for transplants and Mycamine is Astellas’ antifungal drug used to treat post-operative fungal infections; Vaprisol is used for the treatment of hyponatremia

  • Conducted in-depth quality assurance assessments of all regulated documents and the critical review of corporate IND and NDA submissions; assured data integrity, completeness, accuracy and adherence to FDA regulations and ICH and FDA guidelines

  • Performed detailed electronic quality assurance reviews of all regulatory submissions to ensure compliance with FDA guidelines and regulations

  • Acted as project leader with respect to the document review process for the assigned IND and NDA projects

  • Coordinated and oversaw document review activities of temporary personnel and consultants; provided direction to and guidance of QA procedures; prioritized work to assure timely completion of assigned projects

  • Supervised issue resolution of all documents and submissions including but not limited to protocols, pre-clinical study reports, clinical study reports, patient narratives, investigator’s brochures, periodic safety update reports, IND and NDA annual reports, proposed and approved product labeling, CMC documents, briefing documents and IND and NDA submissions

  • Interfaced directly with project team members and all levels of management; participated in interdepartmental meetings between Medical Writing, Regulatory Affairs, Quality Assurance, Clinical Research, Biostatistics & Programming, and other departments to follow NDA and IND projects through to successful completion 

  • Managed and tracked all QA department’s project timelines and workloads including objectives, comments, and dates of every incoming and outgoing assignment project

  • Compiled and presented departmental metrics to justify much needed headcount for ever increasing workload

  • Effectively communicated input and project status across departments and cross-cultural (Japanese) environments 

 

2004-2005

Abbott Laboratories                    

Word Processing Coordinator/Document Specialist

 

  • Experienced in the formatting and creation of Clinical Study Reports, Clinical Protocols, Investigator Brochures, Amendments, NDAs, Annual Reports, Case Report Forms, Clinical Summaries, CMC documents, etc.

  • Assisted in the e-Submissions process of Meridia (Sibutramine-238), Zemplar Capsule to the FDA, and the sNDA for Sibutramine Pediatric

  • Project Leader for Package Insert conversion (Word to XML) of more than 65 Abbott drugs

  • Spearheaded Team Mission Statement and completed project ahead of schedule

  • Completed projects outside of regular Word Processing duties including assisting in the creation of the Pharmacogenetic Report template, PowerPoint presentations, modification of graphical images, PDF files, and project management

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EDUCATIONAL EXPERIENCE

 

2000-2003

Tyndale University College & Seminary

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  • Master of Divinity

  • Mastered critical analysis, review, and writing skills through high standard of Masters program requirements

  • Read over 100 books and wrote countless essays and reviews as part of program requirements completing Masters degree in shortest time possible (3 years)

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1995-1999 

McGill University

 

  • B. A., East Asian Studies & Religious Studies

  • RELEVANT COURSEWORK: biology, general chemistry, organic chemistry, microbiology & immunology, genetics, calculus, general physics, anthropology, psychology and statistics

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RELATED EDUCATIONAL EXPERIENCES

2001-2003      

Vision X Toronto

Director

 

  • Volunteered as board member and director of Vision X – a committee comprised of various members of the community designed to instill leadership in young people through bi-annual conferences

  • Planned, organized, and oversaw events for up to 450 people at a time

  • Attended monthly meetings and served as a liaison between Vision X and various other organizations in community

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SKILLS

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  • Member of American Medical Writers Association

  • Brief summary of training: GCP Training, Ethics and Compliance Training, Finding Epidemiological Information Using the Incidence & Prevalence Database, Recruitment and Retention in Clinical Trials

  • Windows: 10, 8, 7, Vista, XP, 2000, ME, 98, 95; Macintosh OS X; Microsoft: Word, Excel, PowerPoint, Project, Access, Outlook, Internet Explorer; Adobe: Acrobat; Lotus Notes; EndNotes

  • GDMS (Global Document Management System), Documentum, DOMASYS, Citrix, DCU, GDEX, eCTD authoring and editing

American Medical Writers Association Member
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