Director Of Regulatory Affairs Resume Example Global Clinical Trial Consulting Firm

DIRECTOR OF REGULATORY AFFAIRS

Professional Summary

Knowledgeable Biotechnology and Pharmaceutical professional with 9 years of industry experience working in various functions including; commercial operations, marketing, regulatory, business development, medical affairs and clinical trials. I am well organized, diligent, and adept at coordination and management of various projects, products, and functions. I'm highly collaborative and hard working with clear and concise attention to details. I'm enthusiastic and eager to contribute to team, products, and company success.

Skills

Change Management
Compliance assurance
Project Management
Problem resolution
Process improvement
Product Information
Standard operating procedures

Product portfolio oversight
Submission preparation
Business operations
MS Office
Federal Drug Administration
Risk mitigation and strategy
Operational planning

Work History

04/2017 to 02/2020Director of Regulatory AffairsGlobal Clinical Trial Consulting Firm | New York, NY

Worked with principal investigators and sponsors to facilitate, review, and document trial activities and comply with research protocols.
Completed review of informed consents and IRB review.
Drove operational improvements which resulted in savings and improved profit margins.
Resolved conflicts and negotiated mutually beneficial agreements between sponsors, principal investigators and regulatory agencies.
Worked with governance committees to make and evaluate promotional print, digital and social media plans.
Analyzed clinical trials studies and reports, compiled information and submitted concise and informative summaries to sponsors, regulatory agencies and investigate sites.
Reviewed promotional materials and contracts to ensure state, federal, global, and industry guidelines were adhered to.
Directed and coordinated with US and Global regulatory authorities and representatives to manage filings, applications and reports.
Determined appropriateness of phase 1 through post marketing clinical trials and studies to protect sponsors, investigators and patients to minimize and determine appropriate risks.
Monitored social media and online sources for industry trends and guidelines for development of advertising and promotional materials.
Monitored and created control reporting to track performance of system and process integrity, vendors, internal workflows and SLAs.

05/2014 to 04/2017Sr. Marketing Communications Specialist Biogen | Cambridge, MA

Supervised marketing for product launches, including public relations tasks, direct mail pieces, trade shows, sales training and e-mail blasts.
Partnered cross-functionally to facilitate marketing opportunities to support brand objectives.
Managed Promotional Review Committee process and meetings for companies top product.
Resolved conflicts and negotiated advertising agreements with cross functional teams; including regulatory, legal, medical, compliance and promotional marketing and public affairs teams.
Drove implementation of marketing operations and review committee handbook and guidelines inclusive of industry standards to drive efficiency within the commerical function.
Launched various products and facilitated marketing material submissions, review and dissemination.
Drove RFP process for print managed services.
Partnered with technical teams and cross functional partners to implement VEEVA vault and Sales Force including legacy system transfer, field sales and internal training.
Managed promotional review committee consultants.
Developed product sampling SOP, compliance documents, regulatory filings, and managed vendor operations.

04/2011 to 06/2013HCV Marketing Product ManagerVertex Pharmaceuticals | Cambridge, MA

Managed product development lifecycle and timelines from conception to dissemination.
Developed marketing content such as blogs, promotional materials and advertisements for social media.
Created digital treatment algorithm for patients, providers, and payers to calculate their chance of achieving a cure with INCIVEK, based upon US prescribing information and applicable clinical trial data inclusive of retrospective analysis.
Marketing and Operations lead for implementation of promotional review committee digital asset system and online review of product materials.
Partnered with cross functional colleagues for RFP, selection and implantation of print managed services vendor resulting in significant cost savings for company.
Managed promotional fulfillment vendor for both commercial and medical materials.
Enhanced product and pipeline profitability to achieve marketing objectives and drive productivity and growth from concept to implementation.
USPI label update lead; including the prioritization of promotional and medical materials implementation to ensure regulatory requirements were met by given applicable deadlines.
Developed product packaging.
Built and strengthened strategic relationships with vendors, advertising agencies and cross functional colleagues.

Education

2011Bachelor of Science | Marketing Mangement Western Governors University, Salt Lake City, UT

Neuroscience Massachusetts Institute of Technology, Cambridge, MA

Certifications

Foster Rosenblatt Marketing Pharmaceuticals
Project Management Professional (PMP)
Visio
Salesforce
Veeva Vault

Resume Overview

Companies Worked For:

Global Clinical Trial Consulting Firm
Biogen
Vertex Pharmaceuticals

School Attended

Western Governors University
Massachusetts Institute of Technology

Job Titles Held:

Director of Regulatory Affairs
Sr. Marketing Communications Specialist
HCV Marketing Product Manager

Degrees

2011 Bachelor of Science | Marketing Mangement
Neuroscience

Director of Regulatory Affairs Resume Example

Resume Score: 80%

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