With broad and deep therapeutic experience across major and small pharmaceutical and device companies, principal consultant Ms. Lori MacCausland, MS is an expert scientific writer and editor with 30 years management experience. Ms. MacCausland earned a Master of Science degree in regulatory technical writing and professional communication and computer programming from Northeastern University, Boston, MA and a Bachelor of Science degree in botany, zoology, and art from the University of Maine. Her business is in Maine, U.S. EST and accomodates global online schedules.

DELIVERABLE EXPERIENCE

Clinical: Audit Plan and Report, Case Report Forms (CFs), Clinical Investigative Plan (CIP), Clinical Development Plan (CDP), Clinical Study Report (CSR), Clinical Summary, Data Management Plan, Development Safety Update Report (DSUR), Informed Consent, Monitoring Report, Pharmacy Manual, Periodic Benefit Risk Assessment Report (PBRER), Standard Operating Procedures (SOPs), Statistical Report, Study Monitoring Plan, and Use-Related Risk Analysis (URRA).

Medical: Abstract, Adverse Event Reports, Annual Report, Design Dossiers, Manuscripts, Package Insert, Patient Narratives, Protocol, Periodic Safety Reports (PSURs), Post Market Surveillance Report (PMSR), Safety Narratives, Serious Adverse Event Reporting, and Technical Papers.

Regulatory: Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Annual Reports, Assay Methods, Assessment Reports, Chemistry, Manufacturing, and Controls (CMC), Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CERs), Design Dossier, Common Technical Document (ICH-CTD) Modules 1,2, 3, and 5, Device History File (DHF), 510(k), Information Responses (IR), Interact Meeting Presentation, Investigative Device Application (IDE), Instructions for Use (IFU), Investigative New Drug Application (pre-IND/IND), Investigator Brochure (IB), Labeling, Literature Searches, Marketing Authorization Submissions (MAA), Meeting Request Letter (MRL), New Drug Application (NDA) Summaries, Notice of Change, Post Approval Supplements (PAS), Post-Market Clinical Reports (PMCRs), Pediatric Study Plan (iPSP), QSub, Premarket Notification (510(k), Premarket Approval (PMA), Process Validations, Reformulation Studies, Registration Renewals, Response to Health Authorities, Stability Studies, FDA presentation slides. Technical Files, Trial Master File (TMF), United States Prescribing Information (USPI).

Business: Analytical Plans/Reports, Budget, Business Plan, Charter, Communications Plan, Confidential Disclosure Agreement, Contracts, Cost Analysis, DMAIC/A3, Financial Forecast, Flowchart, Gap Analysis, Gantt Chart, Grant, Integrated Development Plan (IDP), License, Meeting Minutes, Market Analysis Plan, MS      Project Schedule, Press Release, Project Charter, Proposal, Quality Policy, Request for Proposals Responses (RFP); Risk Mitigation Plan, Specifications, Statement of Work, Status Dashboard, Target Product Profile (TPP), Trackwise Plan, Validation and Verification Plans, and Websites.