Cindy Willis

Cindy Willis Email and Phone Number

Principal Writer, Medical Writing | Alnylam Pharmaceuticals @ Alnylam Pharmaceuticals
Kirkland, WA, US
Cindy Willis's Location
Greater Seattle Area, United States, United States
Cindy Willis's Contact Details

Cindy Willis personal email

n/a
About Cindy Willis

Medical writing professional with experience preparing clinical and nonclinical documents from IND through summary documents in the BLA that includes driving document strategy and key messages. Lead medical writer preparing investigator brochures, clinical protocols and protocol amendments (phases 1-3 and observational), informed consent forms, clinical study reports, safety narratives, development safety update reports, clinical and nonclinical CTD module 2 summaries, R&D research reports (pharmacology, toxicology, PK), and manuscripts. Proficient in developing standard operating procedures, templates, and internal guidelines for regulatory document preparation. Thorough understanding of FDA and EU GCP regulations. Management-level positions in staff development, mentoring and management of direct reports, and oversight of external writers. My colleagues know me as detail-oriented, analytical, and a clear communicator who facilitates driving results.

Cindy Willis's Current Company Details
Alnylam Pharmaceuticals

Alnylam Pharmaceuticals

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Principal Writer, Medical Writing | Alnylam Pharmaceuticals
Kirkland, WA, US
Website:
alnylam.com
Employees:
2585
Cindy Willis Work Experience Details
  • Alnylam Pharmaceuticals
    Alnylam Pharmaceuticals
    Kirkland, Wa, Us
  • Alnylam Pharmaceuticals
    Principal Writer
    Alnylam Pharmaceuticals Feb 2024 - Present
    Cambridge, Massachusetts, Us
  • Replimune
    Director, Medical Writing
    Replimune Oct 2023 - Feb 2024
    Woburn, Ma, Us
  • Replimune
    Associate Director, Medical Writing
    Replimune Apr 2022 - Oct 2023
    Woburn, Ma, Us
  • Replimune
    Senior Manager, Medical Writing
    Replimune Sep 2021 - Apr 2022
    Woburn, Ma, Us
  • Rakuten Medical
    Senior Manager Medical Writing
    Rakuten Medical Jan 2021 - Sep 2021
    San Diego, California, Us
  • Rakuten Medical
    Manager Medical Writing
    Rakuten Medical Dec 2019 - Jan 2021
    San Diego, California, Us
  • Cascadia Drug Development Group
    Affiliate
    Cascadia Drug Development Group Mar 2016 - Dec 2019
    Seattle, Wa, Us
  • Willis Consulting Group, Llc
    Principal
    Willis Consulting Group, Llc Nov 2014 - Dec 2019
    • Scientific and Medical Writing: drafting, revising, and editing scientific and medical documents (e.g. abstracts, posters, presentation slides, journal manuscripts, non-clinical study reports) for biotechnology companies, contract research organizations, research-based clinicians, and academics. • Scientific Writing Instructor: Conducted a 2-day, highly rated and proven scientific writing course teaching scientists to communicate effectively and efficiently about their research.• Biotech Consultant: Provided research support consultation services for the biopharmaceutical industry for conference coverage, target assessment, literature summaries, due diligence, and interpretation of data sets for oncology, autoimmune, and inflammatory diseases.
  • Amgen, Inc.
    Senior Scientist
    Amgen, Inc. Mar 2009 - Oct 2014
    Thousand Oaks, Ca, Us
    Research project team leader and research analytics• Led 2 multi-disciplinary, multi-site, team-based projects to screen and develop large-molecule drugs for autoimmune and inflammatory indications • Provided preclinical model expertise to build therapeutic rationale for autoimmune and inflammatory diseases• Supervised and mentored 2-person teams, including associates, scientists and international PhD student interns• Led and organized multi-disciplinary working groups to develop new targets and biomarkers for lupus and COPD• Managed and analyzed complex flow cytometry and microarray data sets from mouse models of lupus and human lupus blood samples to identify new targets for treating lupus• Designed and conducted various T-cell, B-cell, and macrophage assays for target validation, drug coverage, and drug candidate screening• Designed and coordinated non-human primate studies with contract research organizations for immune challenge, arthritis, asthma, and COPD models• Initiated and coordinated contracts with vendors to obtain fresh human blood, induced sputum, and lungs for target discovery and biomarker development• Initiated and supervised several contracts with collaborators at US and European universities to test concepts and potential drug molecules using technologies outside of Amgen’s expertiseCo-instructor for Scientific Writing Course • Conceived and designed a 2-day scientific writing and reviewing course customized for Amgen Research• Coordinated and co-taught the scientific writing course for all Amgen research sites, conducting several courses per yearVoting Member of Institutional Animal Care and Use Committee • 3-site IACUC committee responsible for reviewing and approving animal use protocols, conducting vivarium quarterly inspections, and updating program guidelines
  • Amgen, Inc.
    Scientist
    Amgen, Inc. Jun 2004 - Mar 2009
    Thousand Oaks, Ca, Us
    • Trained and supervised peers in transgenic and knockout mouse production and maintenance of colonies• Had increasing responsibility for determining phenotypes of transgenic and knockout mice. Led team efforts to design and conduct studies to understand transgene and knockout gene effects. • Trained and mentored PhD post-docs in techniques for assessing knockout mouse phenotypes; designed and implemented in vivo and in vitro assays for assessing complex knockout mouse phenotypes• Lead biology representative on a multi-disciplinary, team-based project with responsibility to design and conduct in vivo immune challenge and autoimmunity models to validate CD30L
  • Immunex
    Scientist/Senior Research Associate
    Immunex May 1992 - Jun 2004
    Us
    • Developed new mouse embryonic stem cell lines. Cloned mouse knockout DNA constructs, screened and produced mouse embryonic stem cells to produce knockout mice.• Microinjected mouse embryos to create mice genetically deficient in novel Immunex molecules • Organized breeding schemes for double and triple knockout mouse colonies• Microinjected mouse oocytes to produce transgenic mice expressing several novel Immunex cytokines, cytokine receptors, and TNF family members• Genotyped transgenic mice, screened mice for transgene expression, and maintained breeding and production colonies of transgenic mice• Cloned and produced DNA transgenic constructs for microinjection

Cindy Willis Skills

Biotechnology Immunology Drug Discovery Antibodies Assay Development Biopharmaceuticals Life Sciences Drug Development Monoclonal Antibodies In Vivo Biomarkers Cell Immunoassays Scientific Writing In Vitro Inflammation High Throughput Screening Medical Writing Teaching Writing Cell Biology

Cindy Willis Education Details

  • University Of Idaho
    University Of Idaho
    Microbiology And Immunology; Minor Chemistry

Frequently Asked Questions about Cindy Willis

What company does Cindy Willis work for?

Cindy Willis works for Alnylam Pharmaceuticals

What is Cindy Willis's role at the current company?

Cindy Willis's current role is Principal Writer, Medical Writing | Alnylam Pharmaceuticals.

What is Cindy Willis's email address?

Cindy Willis's email address is wi****@****gen.com

What schools did Cindy Willis attend?

Cindy Willis attended University Of Idaho.

What skills is Cindy Willis known for?

Cindy Willis has skills like Biotechnology, Immunology, Drug Discovery, Antibodies, Assay Development, Biopharmaceuticals, Life Sciences, Drug Development, Monoclonal Antibodies, In Vivo, Biomarkers, Cell.

Who are Cindy Willis's colleagues?

Cindy Willis's colleagues are John Shimkus, Bridget (Cloonan) Rothwell, Pharmd, Rph, Kristal Touchstone, Jessica Bombardier, Wihann Kotze Ca(Sa), Simona Gulli, Samip Dhakal.

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