Ann Dougherty Email & Phone Number

Waltham, Ma, Us

Boston, Massachusetts, Us

Cambridge, Massachusetts, Us

Cambridge, Massachusetts, Us

Us

Forum Pharmaceuticals Inc. (FORUM) is focused on the development of medications for central nervous system diseases, including schizophrenia, Alzheimer’s disease, and frontotemporal dementia. I authored or managed the development of several regulatory documents, including both clinical and nonclinical documents. Key accomplishments include: Managed the development and revision of several Clinical Study Reports by external vendors ensuring timely completion and submission. Collaborated with several functions on the preparation of Nonclinical NDA summary documents to facilitate an NDA submission. Authored the Nonclinical Overview, Pharmacology Written Summary, and Pharmacokinetics Written Summary with subject matter experts and acted as a reviewer on the Toxicology Written Summary and all tabulated summaries. Authored and revised several clinical regulatory documents, including protocols, protocol amendments, Investigator Brochure updates, and a Data Safety Update Report with input from multiple functional areas. Member of cross-functional team planning and developing the Integrated Summary of Efficacy Statistical Analysis Plan and shell document. Developed or updated SOPs, including the SOPS for Clinical Study Reports, Investigator Brochures, and Protocols, to ensure Good Clinical Practice (GCP) compliance. Key member of a cross-functional team to implement VeevaVault and PleaseReview as the company-wide document management and review software systems.

Waltham, Massachusetts, Us

TESARO is focused on the development of oncology medications. While at TESARO, I collaborated with cross-functional team members to author or manage the development of several regulatory documents. Key responsibilities were as follows:Provided medical writing support for the preparation of protocol amendments, Investigator Brochures, Investigational Medicinal Product Dossiers, and other clinical and regulatory documents.Managed review process of Clinical Study Reports authored by external vendors for timely completion and submission. Worked with medical writing vendors to prepare timelines and work plans for NDA submission.

Boston, Massachusetts, Us

AVEO Oncology is focused on the development of oncology medications. While at AVEO, I authored both clinical and nonclinical regulatory documents, primarily to support an NDA submission. Key accomplishments included: Collaborated with subject matter experts to author and revise the Clinical Pharmacology Summary, portions of the Integrated Safety Summary, the Nonclinical Pharmacology Summary, and the Nonclinical Overview facilitating an NDA submission. Wrote Investigator Brochures, Briefing Books, DSURs, Rapid Responses, and other documents to submit to regulatory agencies.Worked on a multi-function initiative to develop a company-wide reference database for organizing copies of literature references and ensuring accurate in-text referencing.Wrote and managed the review process of company SOPs, including the SOPS for Clinical Study Reports, Investigator Brochures, and registering on ClinicalTrials.gov

East Hanover, Nj, Us

I transitioned to medical writing while at The Medicines Company. As a Medical Writer, I collaborated with subject matter experts across functional areas to author clinical documents. Key responsibilities included:Wrote and manage the revision of Clinical Study Reports, Investigator’s Brochures, Briefing Books, Annual Reports, and other documents for submission to regulatory agencies.Wrote and/or edited manuscripts for submission to scientific journals.Reviewed and summarized articles pertaining to antibiotics each week for a company update.my responsibilities included:

Targanta Therapeutics Corporation was focused on the development of an antibiotic for acute bacterial skin and skin structure infections. Targanta was acquired by The Medicines Company in February 2009. The Medicines Company is focused on the development of critical care medications. As a Submissions Specialist, I edited, formatted, and published documents for inclusion in an NDA. In addition, I gained some exposure to medical writing projects under the supervision of a mentor. Key accomplishments included:Formatted, edited, and published documents for US NDA and EU Marketing Authorisation Application electronic Common Technical Document (eCTD) submissions. Coordinated transfer of published documents to the vendor compiling the eCTD.Key person responsible for eCTD submission bibliography, company references, and literature searches and databases.Supported Targanta activities for a Food and Drug Administration (FDA) Advisory Committee Meeting, a face-to-face meeting with the FDA, and an on-site FDA audit. Created functional document templates for regulatory documents.Worked with a mentoring medical writer to author clinical study protocols.

inVentiv Clinical Solutions and Medfocus LLC (a division of inVentiv) provide contract research services to Eli Lilly and Company and Targanta Therapeutics Corporation. As a Submission Bibliography Coordinator, I prrovided contract Submission Bibliography Coordination and Editorial Support for both Eli Lilly and Company and Targanta Therapeutics Corporation. Key responsibilities included:Coordinated with writers, editors, library personnel and publishers to ensure inclusion of all reference materials in regulatory submissions.Project managed multiple regulatory submission bibliographies simultaneously.Edited regulatory documents such as protocols and clinical study reports, according to American Medical Association (AMA) and company style guides. Assembled and formatted posters for scientific congresses.Performed extensive literature searches via online sources.Created and utilized multiple reference databases including EndNote and Reference Manager.