Mohsen Niknam

Scientific professional with extensive experience in medical device clinical trials and processes. Extensive experience in medical writing, including CEPs, CERs, PMCFP, PMCFR, PMS plan, WI, and SOPs. Significant experience in resource management, contract review and negotiation.

Effective project planner who excels at managing several projects simultaneously. Ability to form cross-functional teams to achieve desired results. Excellent interpersonal and communication skills with demonstrated ability to establish productive relationships with researchers, government, KOL, CRO, and other stakeholders.

Sr. Medical Writer/ Clinical Scientist - Hologic Inc. - Boston MA

(2025-04)

• Authoring CEPs, CERS, PMCFs and PMCF Reports

Sr. Medical Writer - Haemonetics - Boston MA

(2020-11 - 2025-03)

• Created and updated CEP and CER Templates, WI, SOPs
• Created PMCF Plan and Report Templates per all MDCG Guidance, WI, SOPs
• Managed 14 CERs (Software and devices)
• Managed 5 CRO writers
• Perform Gap Assessments of all clinical docs meeting MDR requirements
• Identifying appropriate sources of relevant information and data
• Compliance with Good Documentation Practices to ensure quality and accuracy for each document content
• Compliance with all SOPs, Regulatory Docs, US and OUS Guidelines
• Creating Acceptance Criteria for each Claim with respected approved sources
• Managed all Master contracts, SOWs, Invoices
• Review and edit all CEP, CER, PMCF Plan and Reports
• Authoring CEPs, CERS, PMCFs and PMCF Reports
• Prepared Project plan for Clinical Evaluation Reports
• Prepared all CER Literature Search Plan (Subject device and SOTA)
• Prepare CER and PMCF timelines
• Review to approve PMSR, PSUR
• PMS Literature Search Plan
• Prepared SSCP: summary of safety and clinical performance
• Skilled in EUMDR 2017/745-GSPR and MMD-ESR, All MDCG Guidance and required compliance, ISO 14971
• Review and approve Post market clinical follow up: Survey and Studies
• Working with CRO for Generating new PMCF Survey

Clinical Evaluation Specialist - Smiths-Medical ASD - Plymouth MN

(2019-09 - 2020-02)

• CER Reviewer
• Author Clinical Evaluation Plan and Clinical Evaluation Reports
• Updated CEP Template
• Updated CER Template
• Developed PMCF Plan and Report template
• Developed PMS Plan and Reports

Principal Medical Writer/Project Manager - Zimmer Biomet Inc. - Palm Beach Gardens Florida

(2017-11 - 2019-08)

• Manage Clinical Evaluation Reports- Dental Implants Systems
• Author Clinical Evaluation Plan
• Author 7 Clinical Evaluation Reports
• Prepare Peer-reviewed Scientific Literature Analysis and Summary
• Develop Project plan for Clinical Evaluation Reports
• Develop CER and PMCF study timelines
• Develop CER Gap Analysis based MedDev 2.7/1 Rev 4. 2016 and EU MDR 2017/745 (Instruments Class Ir)
• ICH guidelines and GCP guidelines
• Developed CER procedure
• Developed new CER template
• Developed New CER training for Clinical Evaluation Team
• Author and trainer on MedDev 2.7/1Rev 4.2016
• Develop New CER template for MedDev 2.7/1Rev 4.2016 and EUMDR 2017/745 (Class IIb and Class Ir)
• Develop CER Literature Search Plan (Primary and SOTA search)
• Develop PMS Literature Search Plan
• Mange all CER Strategy Meetings, Kickoff meetings, biweekly meetings CER review sessions
• Monthly report to Senior Management (Regulatory and Product Development)
• Trainer on Literature Search Databases
• Working closely with all cross functional teams including Clinical Research Manager, Regulatory, Design Assurance Engineers, Product development, Data Management, Biostatisticians, CER writers, PMS Management
• Manage CROs contracts

Sr. Medical Writer/Project Manager (Contract- Remote) - Medtronic Inc. - Plymouth, MN

(2017-03 - 2018-08)

Managing the execution of clinical-regulatory documents supporting clinical report deliverables, ensuring successful preparation of high-quality submission-ready documents.

• ICH guidelines and GCP guidelines
• PMSR reports
• Develop Project plan for Clinical Evaluation Reports (Stents and Catheters Peripheral, Arterial and endovascular 45)
• Develop CER and Study timelines
• Develop CER Gap Analysis based MedDev 2.7/1 Rev 4. 2016
• Develop CER Search Plan (Primary and SOTA search)
• Manage CROs contracts (6 CER writers and two CROs)
• Primary contact with CROs for Contracts and Regulatory reports
• Arrange and conduct CER Strategy Meetings, Kickoff meetings, biweekly meetings CER review sessions
• Work directly with CER Critical Appraisers (6)
• Trained CER Critical Appraisers on writing CER Critical Reports based on MedDev 2.7/1 (Rev 4)
• Trained new CER Medical Writers on CER
• Working closely with all cross functional teams including Clinical, Regulatory, Design Assurance Engineers, R&D, Data Management, Biostatisticians, CER writers, Complaint Management
• Revised CER template
• Manage all CER approval process
• Ensuring Compliance with appropriate conventions, and correct format requirements per journal/congress, ICH and other governing bodies
• Review of Postmarked Surveillance Reports
• Conduct full edit on each CER before it is released

Regulatory Affairs Consultant (Contract- Remote) - Johnson and Johnson Spine Division DePuy Synthes - Raynham, MA

(2016-02 - 2016-12)

• Developed Clinical Evaluation Report Strategy for Spine Products according to MedDev 2.7/1 Rev 3. 2009 and Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC
• ICH guidelines and GCP guidelines
• Prepared Data Extraction Tables for 12 Spine products (Clinical Literature Summary) sponsored research and analyzed the competitive literature in order to develop proactive planning, Risk Analysis and CAPA
• Reviewed Clinical Evaluation Reports Medical Devices Class IIb (implantable)
• Generated Comparative Device Tables (Subject device and comparators' devices)
• Managed 28 Clinical Evaluation Reports. Spine products
• Generated CER Strategy plan
• Reviewed PMSRs

Clinical Evaluation Reports Specialist (Contract- Remote) - Medtronic PLC. Spine - Memphis, TN

(2015-10 - 2016-02)

• Developed Clinical Evaluation Reports for Spine Products according to MedDev 2.7/1 Rev 3. 2009 and Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC
• Worked Medical Devices Class IIb (implantable)
• Conducted Clinical Data Search, Risk Analysis, Complaints, Recall and CAPA
• ICH and GCP guidelines

Clinical Research Scientist - Smiths-Medical ASD Inc. - St. Paul, MN

(2013-02 - 2015-08)

• Authored and Reviewed Clinical Evaluation Reports according to MedDev 2.7/1 Rev.3.2009 and Medical Device Directive 93/42/EEC as amended by Directive 2007/47/EC
• Authored PMSRs
• Provided clinical input for new product development, post market surveillance, recertification and business development
• Provided direct communication between Sales and Marketing, R&D, Regulatory Affairs, Senior Management, Key Opinion Leaders/Investigators
• Managed vendor contracts
• Presented scientific data by communicating accurate, succinct summaries of clinical study work at industry gatherings
• Provided accurate monthly progress reports on CERs
• Obtained Recall, Hazard reports, and field Safety Reports (FDA, MEHRA, Canada Heath, and TGA)
• Audited Technical Files for Audit and CE Submissions
• Authored Replies to Auditors' Non-Compliance Reports
• Prepared Complaint History Reports, CAPA reports and Device History Reports
• Authored Clinical Literature Review using Publication Rating System (Harbour and Miller 2001)
• Prepared Equivalent Device Matrix (Clinical, Biological and Technical)
• 9 years of clinical experience in Medical Devices Class I, II, and III
• Managed multiple tasks
• Ability to adapt to a changing work environment and make independent decisions
• ICH guidelines and GCP guidelines
• Authored 40 Clinical Evaluation Reports
• Close cooperation with Quality system engineers, Global Program Managers, Marketing, Regulatory, Research and Development in order to assist in clinical strategy, the development of study plans, and project deliverables
• Managed project schedule, timelines and deliverables
• Technical knowledge of over 15 lines of products including Central Vascular Access Interventional Imaging (Angiograph catheters), Respiratory Air Way products, Pain Management, and Temperature Management products

Clinical Research Associate - University of Minnesota - Minneapolis, MN

(2013-01 - 2013-12)

• Worked closely with Scientists, Quality control and Regulatory groups and IRB
• Negotiated and prepared contracts, Budget, publication, clinical study protocols
• Training new graduate students

Instructor - National American University - Bloomington, MN

(2010-01 - 2011-12)

• Human Anatomy and Physiology
• Human Pathophysiology
• Microbiology
• Human Nutrition
• Introductory to Pharmacology I and II

Clinical Project Manager - ElectroCore LLC - Basking Ridge, NJ

(2008-01 - 2009-12)

• Prepared Revision of Clinical Study plan- IDE Study
• Prepared CRFs
• Prepared PowerPoint Training materials on device, GCP, Study Protocol, Monitoring plan
• ICH and GCP Guidelines
• Conducted Site selection, Site activation, Site monitoring visits
• Managed Site Contracts, payments and resolving QC coordination of publication
• Trainer in Good clinical practices (GCPs), standard operating procedures (SOPs), FDA Regulatory Standards, HIPAA, Informed consent form and IRB compliance
• Prepared Budget, Publication and Monitoring Plan
• Generated Communication with FDA on Protocol revision and CRFs, PMA follow ups

Clinical Project Manager - 3M Inc. Medical Division - Maplewood, MN

(2007-01 - 2007-12)

• Prepared Clinical Study Plan
• Prepared CRFs, Monitoring plan, Publication database, publication plan
• Prepared PowerPoint Training materials on device, GCP, Study Protocol, Monitoring plan, ICF, IRB compliance
• ICH and GCP guidelines

Senior Clinical Trial Leader - Medtronic Inc. - Minneapolis, MN

(2003-01 - 2007-12)

• Prepared Clinical Study Plan IDE and post market studies
• Served as Core Team Clinical Representative
• Worked effectively with core project team members to set timelines and meet goals, developed and managed clinical study budgets
• Developed protocols, CRFs, study documents, and study monitoring plans
• Developed and reviewed SOP documentation
• Conducted study monitoring visits and created trending reports
• Created clinical study training materials and trained study investigators/coordinators
• Worked with legal for development of clinical trial agreements and negotiated appropriate compensation with sites
• Attended device implant procedures as clinical representative; provided physician feedback to R&D and marketing to assist with product development/improvement
• Worked with statisticians to design clinical trials, create statistical plans, and conduct data analyses for reports and manuscripts
• Worked with regulatory to provide documents for FDA submissions

Sr. Clinical Research Associate - University of Minnesota - Minneapolis, MN

(2001-01 - 2003-12)

Working on Molecular Biology of Neuropsychiatric disorders: Autism, Bipolar, Depression

Postdoctoral fellowship - University of Arizona - Tucson, AZ

(1998-01 - 2000-12)

Department of Family and Community Medicine. Project: Effects of Pycnogenol supplementation on heavy smokers' platelets reactivity Index. Ronal Ross Watson Ph.D., Advisor

Ph.D. - Nutrition/Microbiology and Immunology Sciences - University of Arizona

M.S. - Biology - California State University of Dominguez Hills

B.A. - Biology - California State University of Dominguez Hills