Summary
Overview
Work History
Education
Skills
Websites
Certification
Hobbies and Interests
Publications
Timeline
Generic

Michelle Vanase

Norwich

Summary

Accomplished medical writing professional with extensive experience in document project management, content development, publications, and cross-functional collaboration within the pharmaceutical industry. Adept at transforming complex clinical data into clear, impactful communications that align with internal and regulatory standards. Proven ability to lead high-performing teams and drive messaging consistency across programs. Experienced in implementing process improvements and standards. Dedicated to scientific integrity, ongoing professional growth, and advancing solutions that improve the lives of patients.

Overview

28
28
years of professional experience
1
1
Certification

Work History

Clinical Scientist Communications Lead – Senior Manager, Vaccines Clinical R&D

PFIZER, INC
Groton
03.2023 - 06.2025
  • Provided leadership, scientific expertise and project management to the creation of high-quality regulatory documents for clinical research trials.
  • Drove content planning and writing strategy under minimal supervision, completing multiple medical writing projects across 6 or more study teams, concurrently.
  • Contributed to the writing and review of complex clinical documents, such as: clinical study reports and appendices, developmental safety update reports, study protocols, investigator brochures, clinical development plans, safety narratives, and end-of-study investigator data packages.
  • Created and edited abstracts, posters and presentations.
  • Reviewed shells and interpreted tables, figures and listings for scientific accuracy; maintained compliance with quality standards and statistical analysis plans.
  • Collaborated cross-functionally with internal and external groups (clinical, safety, medical writing, etc.) to execute document plans and meet aggressive timelines for regulatory submissions.
  • Coordinated the quality review process; resolved reviewer inquiries/issues and managed approval workflows.
  • Served as subject matter expert for document standards to maintain accuracy, grammar, format and content integrity.
  • Developed/maintained templates and guidelines; mentored team members (clinicians, medical writers, etc.) in usage.
  • Ensured written content adhered to appropriate writing conventions, including global and program-specific style guides, regulatory standards and standard operating procedures.
  • Led administrative tasks, such as creating and maintaining timelines, updating deliverable trackers, and hosting meetings.
  • Participated in a process improvement workstream to streamline the design and management of clinical development plans, resulting in the implementation of a new template and training materials used by ~50 study teams.

Clinical Study Manager, Global Site & Study Operations

PFIZER, INC
Groton
05.2018 - 03.2023
  • Managed clinical operations in multiple therapeutic areas, from study startup through database release/close-out.
  • Authored and reviewed study documents including monitoring plans, biospecimen management plans and vendor management plans, per standard operating procedure requirements.
  • Contributed to the creation and review of clinical study report appendices, ensuring accuracy and alignment with regulatory requirements.
  • Created, edited, and distributed 17 global study newsletters, effectively communicating study updates to hundreds of clinical sites in more than 20 countries.
  • Ensured audit preparedness through reconciliation and quality maintenance of the trial master file (TMF).
  • Collaborated with internal study teams (clinicians, data management, etc.) to mitigate study protocol deviations.
  • Demonstrated strong project management skills through oversight of clinical research organizations (CROs) and external vendors, resolving logistical issues to drive forward study timelines.
  • Enhanced operational efficiency through supervision of vendor team performance to meet key deliverables.
  • Partnered with finance to manage resourcing and budget requirements and complete investigator site payments.
  • Served as sponsor representative for several thousand contract employees, facilitating onboarding, training compliance, and system access to promote strategic collaboration with outsourced partners.
  • Presented operational updates to study teams in cross-functional meetings.

Medical Writing Secondment

PFIZER, INC
Groton
06.2021 - 12.2021
  • Trained in regulatory writing principles, QC procedures, and clinical content development.
  • Drafted safety sections for a supplemental NDA.
  • Interpreted statistical and clinical data, incorporated reviewer comments.
  • Educated on the creation of the clinical protocols, clinical study reports, regulatory responses and AMA style.

Scientist, Worldwide Research & Development, Primary Pharmacology

PFIZER, INC
Groton
09.1997 - 05.2018
  • Collaborated on cross-functional project teams to advance the discovery of novel therapeutic compounds.
  • Co-authored and edited and 25 scientific journal publications, preparing manuscripts for peer review.
  • Authored and revised protocol documents, study reports, drug candidate alert notices and legal notebooks.
  • Created and delivered data presentations and posters, internally and at external meetings.
  • Analyzed, interpreted and presented data at team meetings to drive compound structure design.
  • Demonstrated expertise in creating and interpreting tables, graphs, and figures.
  • Independently designed and executed experimental protocols.
  • Demonstrated scientific and technical leadership through outsourced project management.
  • Supervised and mentored less experienced scientists and contractors.
  • Demonstrated computer technology and word processing skills through adept use of MS Word, Excel, and data analysis programs.

Education

Bachelor of Arts, BA - English & Biology

University of Connecticut
Storrs, Connecticut

Skills

  • Medical Writing & Editing
  • Cross-Functional Team Collaboration
  • Project Management Skills
  • Publications
  • Proofreading
  • Time Management
  • Problem-Solving
  • Standard Operating Procedures
  • Relationship Building
  • Attention to Detail
  • Strong Communication Skills
  • Data Interpretation
  • MS Word
  • Excel
  • PowerPoint

Certification

  • Edge Essentials, Leadership Program, Harvard Business Publishing
  • American Medical Writers Association (AMWA) Certification, In Process, 07/01/25

Hobbies and Interests

  • Teaching Yoga
  • Mindfulness & Meditation
  • Volunteering (animal adoption)

Publications

LIST OF PUBLICATIONS AVAILABLE UPON REQUEST

Timeline

Clinical Scientist Communications Lead – Senior Manager, Vaccines Clinical R&D

PFIZER, INC
03.2023 - 06.2025

Medical Writing Secondment

PFIZER, INC
06.2021 - 12.2021

Clinical Study Manager, Global Site & Study Operations

PFIZER, INC
05.2018 - 03.2023

Scientist, Worldwide Research & Development, Primary Pharmacology

PFIZER, INC
09.1997 - 05.2018

Bachelor of Arts, BA - English & Biology

University of Connecticut

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