Patient Care Delivery | Clinical Research | Safety Monitoring | Clinical Trials | Gastroenterology | Immunology

Oncology | Infectious Diseases | Communication | Time Management | Patient & Family Education

EDC Medrio | Medication Coding WHO DD | Windows | DOS | MS Office | Internet Explorer

Competent, capable and focused Licensed Physician with seven years of successful clinical research experience as a Safety Monitor. Serve as a key resource to colleagues and allied health professionals due to expertise gleaned over the course of a diverse medical career. Skilled in serving in numerous other capacities in the medical industry including Internal Medicine Physician, Oncology Trials Sub-Investigator, Primary Care Physician, Hospital Attendant, Nurse and Medical Assistant. Enthusiastic and collaborative team player with extensive medical knowledge and superior writing skills. Leverage strong attention to detail in working within time constraints, both as part of a team or as an independent contributor. Proudly completed an 18-month Internal Medicine Observership at NYU Downtown Hospital and a six-month Psychiatry Observership at RWJ Hospital. Strive to continually surpass organizational expectations in order to deliver positive results. Excel in operating under pressure in a fast-paced setting that calls for flexibility. Seeking an opportunity in the Drug/Pharmacovigilance sector, e.g. Drug Safety Specialist, Pharmacovigilance Scientist and Medical Reviewer roles.

  Assess laboratory results and safety data to craft suitable follow-ups in partnership with study site and sponsor

  Prepare subject narratives and MedWatch reports for SAEs

  Prepare narratives, create tracking logs and request source documents, e.g. MedWatch reports, pregnancy reports, patient profiles and TLGs, from the client

  Assign subject narratives to Medical Writers and review the content of each; develop combined documents containing the narratives for the CSR

  Complete coding for concomitant medications using WHO DD

  Play a key role in carrying out clinical trials; request supplies, process regulatory documents and track central randomization

  Prepare shell of CSR, intext tables, Appendix 16 and CSRs for publishing purposes, as well as for placement in the results sections; touch on core areas including safety, efficacy, pharmacokinetic and pharmacodynamics

  Author protocol amendments, as well as additional clinical and regulatory documents

  Summarize data from clinical studies so that the content is easily digestible and concise

  Spearhead literature searches; also review and edit documents for grammar, clarity, consistency and scientific standards adherence

  Incorporate text, graphs, charts, tables and statistical analysis into writings

  Serve as an effective intermediary between RAI and the client

  Liaise with others as an engaged participant during cross-functional meetings; discuss clinical development, data management, biometrics, drug safety and regulatory affairs

  Rectify the use of erroneous content and inconsistent clinical data per client specifications

  Synthesize complex content, research data and call on background experience to complement data, workflow design and procedures

  Align all operations with medical writing processes to ensure quality, accurate documentation, review, comment resolution/incorporation and finalization

  Partake in timeline development, internal strategic planning and regulatory meeting functions

  Develop technical documents that support domestic and global regulatory submission criteria

  Aided in the completion of clinical projects, including the preparation of clinical and regulatory documents

  Worked as an active participant in presentations and project meetings; learned a great deal and sharpened skills greatly during tenure in role

Continued

  Gathered patients medical history during initial assessment, follow-ups or longitudinal treatment visits

  Completed physical examinations, minor surgical procedures, treatment processes and preventative measures

  Refined knowledge of drugs and their indications, as well as dosing, side effects and administration best practice

  Educated patients and their families as to the nature of their respective disease; offered guidance on proper care and treatment

  Cared for patients before and after ambulatory surgeries; also prepared patients and assisted Doctors during X-ray and ultrasound examinations

  Proved crucial in making important administrative and procedural decisions

  Demonstrated expertise in legal and ethical standards during delivery of comprehensive medical care; included providing chemotherapy treatment on an inpatient and outpatient basis

  Evaluated MRI, CT scan and blood tests results

  Recruited suitable patients within an agreed-upon time frame

  Recorded patients medical histories and completed physical examinations during initial and follow up visits

  Obtained voluntary informed consent from patients prior to their participation in clinical studies; also maintained all study documents and clinical supplies

  Delivered quality patient care during physical examinations; led evaluations and confirmed diagnoses

  Also engaged in maternal/pediatric consultation, facilitated home visits and offered specialized treatment

  Called on expertise in drug metabolism, dosage, indications and interactions to educate patients in correct drug usage and potential side effects

  Participated seminars and lectures organized by the Union of General Practitioners in Bulgaria

Observership, Robert Wood Johnson University Hospital, 2011

Observership, Beth Israel Medical Center, 2008 2010

Volunteer, NYU Downtown Hospital, 2004 2005

Master s Degree in Medicine, Medical University of Sofia (GPA 3.77)

Licensed to Practice as a Physician in Bulgaria

Certificate, Essential Skills, American Medical Writers Association, 2016

Certificate, Medical Writing, CSR, 2015

Course, Project Management, Raritan Valley Community College, 2015

Member, American Medical Writers Association, 2014

Certificate, Educational Commission for Foreign Medical Graduates

Exams, Step 1, 2 CK, 2 CS, 3, United States Medical Licensing Exams (USMLE)

Certificate, CITI GCP Training (Bi-Annual)

66 Glendale Ave. | Piscataway, XXXXXX xxxxxx xxx-xxx-xxxx | abc@xyz.com

March 16, 2018

Hiring Agent Name

Title

Company Name

Address

City/State/Zip Code

Dear [Hiring Agent Name],

I am currently seeking a challenging career opportunity in a (INSERT TITLE OF TARGET POSITION) capacity and am submitting my resume for your review. In advance, thank you for your time and consideration. As demonstrated in the accompanying resume, my professional qualifications include the following accomplishments:

  I bring to any role years of proven success in positons of varying responsibility and scope in the medical sector. I have a career history that includes serving as a Clinical Researcher, Internal Medicine Physician, Oncology Trials Sub-Investigator, Licensed Primary Care Physician, Hospital Attendant, Nurse and Medical Assistant.

  I am currently a Safety Monitor and serve as an expert-level resource to colleagues and other care professionals due to my diverse, global background. However, I hope to secure a role in the Drug/Pharmacovigilance sector. At this time, I am seeking out Drug Safety Specialist, Pharmacovigilance Scientist and Medical Reviewer positions.

  As a professional, I have an innate ability to connect positively with individuals and teams at all levels. All of my experiences thus far prepared me for advancement into a role that calls on my background as a Physician in Europe, yet allows me to leverage these mastered competencies in an exciting, challenging new way.

  To pair with my practical background, I ve completed a Master s Degree in Medicine through the Medical University of Sofia and am licensed to practice medicine in Bulgaria. I ve also completed Observerships and volunteer experiences at renowned hospitals throughout the U.S.

  I ve also engaged in countless certification and credentialing programs including a Project Management course and a certificate program through the American Medical Writers Association.

As an employee, you will find me to be a driven team player committed to supporting you in achieving your objectives through superior performance. I am confident that I could be a valuable asset to your organization, and look forward to interviewing with you in the near future.

Sincerely,

Yyyyyy x. yyyyyy

Enc. Resume