Therapeutic Areas of Expertise

Cardiology ￨ Metabolism ￨ Endocrinology ￨ Hematology ￨ Diagnostic Imaging ￨ Oncology ￨ Psychotherapeutics ￨ Virology

• Dynamic Leader who offers a background in Drug Safety, Pharmacovigilance Case Processing, and Regulatory Medical Writing; contributes talents in Project Management, Clinical Assessments, Team Building / Training, Quality Control, Aggregate Reporting, and Data Management; and exhibits an ability to see the big picture at all times.
• Top Performer who boasts above-average career results, and who can make decisions to reflect positively on scientific operations in alignment with a company s vision, value, and goals to attain a competitive advantage.
• Visionary Professional with commendable accomplishments across strategic pharmacological initiatives, and who can rise above challenges to collaborate with study teams, enhance overall quality, and drive winning outcomes.
• Excellent Communicator who builds and sustains synergistic relationships with senior-level management, SMEs, quality assurance professionals, medical safety teams, physician investigators, biostatisticians, journal editorial boards, and colleagues, and who excels in both autonomous and collaborative work environments.

2014 Present

Senior Scientific Writer Global Regulatory & Scientific Documentation

  Capitalize on the opportunity to coordinate and author safety risk-related aggregate reports necessary for regulatory submissions, including performing quality control review of documents to meet core objectives.

  Apply talents in actively supervising junior medical writers responsible for regulatory document preparation.

  Developed highly valuable strategies for organizing and preparing regulatory documents.

  Participated in Medical Safety Teams to ensure effective planning and management of timelines.

2014

Medical Writing Consultant Oncology

  Utilized broad scope of industry knowledge toward collaborating with clinical study teams, oncology medical writing teams, regulatory affairs personnel, and publishing group to prepare detailed regulatory requirements.

• Prepared regulatory documents in accordance with the ICH guidelines, international regulations, standards, and processes, and handled diverse documents encompassing protocols and protocol amendments.

  Participated in project team meetings to provide input of deliverables, timelines, and processes.

2011 2013

Aggregate Reports Manager Global Pharmacovigilance

  Strategically steered preparation and management of aggregate reports (e.g. DSURs, PSURs, PBRERs, RMPs, addendum reports) for various compounds in diverse stages of clinical development and marketed products.

  Collaborated with Subject Matter Experts (SMEs) and Quality Assurance (QA) personnel on the coordination of production staff which were instrumental in actively ensuring documents maintained high-level compliance.

  Coordinated key efforts with physician investigators, biostatisticians, journal editorial boards, and colleagues.

  Authored safety risk-related document sections needed for regulatory submission.

  Coordinated, collated, and summarized patient exposure data for regulatory reports inclusion.

  Published documents using a customized internal publishing system and archived documents electronically.

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2010 2011

Senior Medical Writer Pharmacovigilance Aggregate Reports

  Expertly led the development of aggregate safety and regulatory reports (e.g. PSURs, Summary Bridging Reports, Periodic Adverse Drug Experience Reports (PADERs), and INDs) for 100+ consumer / OTC products.

  Exhibited sharp analytical abilities toward performing quality reviews for colleagues within the department.

  Planned and conducted solutions-focused meetings.

  Coordinated all facets of production and modification.

  Spearheaded assembly in Documentum and addressed concerns.

2009 2010

Pharmacist Intern

  Demonstrated experience in contacting prescribers to verify prescriptions on dose, duration, proper medications, and / or strength of drug, and accurately processed prescriptions through the insurance company.

  Led targeted resolution of insurance issues, and transferred prescriptions to / from pharmacies as requested.

  Contributed comprehensive experience with Medicaid Part D and Medicaid formularies.

  Objectively recommended OTC medications for patients with diverse self-treatable conditions.

2005 2009

Safety Surveillance Associate ￨ Clinical Safety Associate ￨ Drug Safety Specialist ￨ Consultant

  Played a vital role in processing and tracking serious / non-serious adverse drug reactions and additional medically-related clinical project information, including completing a portfolio of reports for internal and regulatory agency use, as well as participating in timely triage process of incoming medical / scientific documents.

• Expertly conducted clinical assessments on reported serious adverse drug and device experiences (ADEs) in safety databases, and additionally compiled, analyzed, and summarized data for comprehensive study reports.
• Selected and coded (MedDRA) event terms and assessed expectedness / listedness per reference documents.

  Actively generated, reviewed, and updated Adverse Event Reporting Plans.

  Mentored new drug safety staff on safety reporting regulations and processes.

  Wrote summary narratives per SOPs, clinical protocols, and applicable regulations.

Held role as Research Assistant (2003 2004) for the National Institute of Environmental Health Sciences (NIEHS), Research Triangle Park, NC; completed Effects of Influenza Virus Infection on Alveolar Macrophage Apoptosis project.

Doctor of Pharmacy Creighton University

Bachelor of Science in Chemistry Howard University

Extensive Doctoral Toxicology Studies University of North Carolina at Chapel Hill

Domestic Exchange Studies Chemistry Stanford University

Pharmacy-Based Immunization Delivery American Pharmacists Association (Since 2011)

Basic Life Support CPR / AED (Since 2014) ￨ U.S. Diabetes Conversation Map Educator (Since 2012)

International Society for Pharmacoeconomics & Outcomes Research ￨ Healthcare Businesswoman s Association

American Public Health Association ￨ American Society of Health-System Pharmacists ￨ American Pharmacists Association

Meditech ￨ ARGUS ￨ Clintrace ￨ ArisG ￨ SCEPTRE ￨ Documentum ￨ Microsoft Office Suite

Clinical Pharmacy Rotations Upon Request ￨ Publications Upon Request ￨ References Upon Request

Date

Hiring Agent Name

Company Name

Address

City/State/Zip Code

Dear__________________:

I am seeking a challenging [ Insert Job Title ] role, and am submitting my resume for your review.

I am excited to build a rewarding career with your company, and can offer cross-functional experience in Drug Safety, Pharmacovigilance Case Processing, and Regulatory Medical Writing. I am also well-versed in Project Management, Clinical Assessments, Team Building / Training, Quality Control, Aggregate Reporting, and Data Management, among other areas.

To complement my background, please note that I attained a Doctor of Pharmacy from Creighton University and a Bachelor of Science in Chemistry from Howard University. I also completed extensive doctoral studies in Toxicology from the University of North Carolina at Chapel Hill and participated in domestic exchange studies in Chemistry at Stanford University.

Currently, as a Senior Scientific Writer Global Regulatory & Scientific Documentation for Bristol-Myers Squibb, I expertly coordinate and author safety risk-related aggregate reports necessary for regulatory submissions, including performing quality control review of documents to meet core objectives. Within this role, I also successfully supervise top-performing junior medical writers responsible for regulatory document preparation.

A sampling of my achievements include:

  Developing highly valuable strategies for organizing and preparing regulatory documents.

  Participating in Medical Safety Teams to ensure effective planning and management of timelines.

[ Suggestion! Address Here Any Skills / Qualifications / Achievements Relevant to the Job Posting ]. As this is just an example of my abilities, please kindly refer to my enclosed resume for additional experience.

I look forward to hearing from you, and thank you in advance for your careful consideration.

Sincerely,

Yyyyyy x. yyyyyy