Pooja Pahilajani

** ********** ****, **********, ** 08854

(Cell): 201-***-****

advktt@r.postjobfree.com

Professional Qualifications Highlights:

Dual Certificate from RAPS in Medical Device and Pharmaceutical field.

Strong regulatory background includes knowledge of current federal guidelines, FDA/USDA regulations, 21 CFR, SOP preparation, streamlining of procedures and updated good laboratory practices (GLP)

Good knowledge of Pharmacovigilance, RA and IEC i7submissions.

Strong interest in learning to write CERs (Clinical Evaluation Reports)

Knowledge of drug development processes.

Excellent knowledge of Medical terminology and Medical Literature

Knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs, e.g. 21 CFR Part 11 and knowledge of US and International regulations for regulatory approval of products.

Knowledge and understanding of the development process of eCTD submissions

Excellent written and verbal communication skills, excellent writing and editing skills including grammar and syntax editing. Accustomed to working with teams.

Experience with AMA style writing.

Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production.

Proficient with Computer skills like MS Project, MS Word, MS Excel,

MS PowerPoint, MS Access and LIMS (laboratory data management tool).

Can quickly master new computer applications.

Time management, organization and planning skills, multi-tasking and prioritization skills in a fast-paced environment are required.

Ability to maintain a high level of accuracy and attention to detail.

Knowledge in reviewing health related literature and articles for journals, books and health related websites.

Excellent grammatical, editorial and proofreading skills. Also, knowledge in copy editing and data verification.

Proficiency and good knowledge of Medical Literature searches using PubMed and Google Scholar

Education:

Certificate in Pharmaceuticals and Medical Devices from RAPS - November 2015

GPA 3.8

Masters in Health Science, MGM Medical College, Indore, India -June 2003

Experience

3M San Antonio, TX:

September 2022 to present.

Uses scientific or clinical knowledge, writing, and analytical skills to research, create, develop, edit, format, and proof read medical/scientific publications in English. Experience writing abstracts using AMA style.

Writing experience of regulatory documents such as clinical study protocols and study reports, patient narratives, informed consent forms, CTD documents or similar in a contract research organization with experience in conduct of clinical research/medical communications.

Advanced word processing skills, experience with Microsoft Office software including, but not limited to Word, Excel, Access, and PowerPoint (or other similar PC programs).

Produces medical/scientific publications (abstracts, posters, manuscripts, etc.) that conform to applicable journal and conference guidelines.

Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.

Assists to develop supplements and other materials, as needed.

Good knowledge of routine document content preparation, including the use of style guides, medical dictionaries and regulatory documents and templates.

Develops and maintains familiarity with product literature.

Provide support in the development of submission level documents under guidance of Manager and works closely with other team members as needed

Demonstrated writing, critical thinking and analytical skills.

Freelance Health Writer:

Nov 2021 to September 2022

Created health contents and infographics for non technical audiences about health topics and awareness.

Richmond Physical Therapy, NY Aug 2015 - Present

Physical Therapist (Part Time)

Diagnose and manage movement dysfunction and enhance physical and functional abilities.

Perform balance therapy, vestibular rehabilitation and treatment of post surgical shoulders

Meets the patient's goals and needs and provides quality care by assessing and interpreting evaluations and test results; determining physical therapy treatment plans in consultation with physicians or by prescription.

Evaluate effects of physical therapy treatments and fit of prosthetic and orthotic devices by observing, noting and evaluating patient’s progress; recommending adjustments and modifications.

Documents patient care services by charting in patient and department records.

July 2009 – November 2014

Worked as Full-time Physical Therapist at various Outpatient, Hospitals and Skilled Nursing facilities across NY boroughs.

Clients:

Neurology Consultants of New York, NY, NY

Vanderbilt Rehabilitation Center, Staten Island, NY

Ramapo Manor, Monsey, NY

Raymond Nafthali Ambulatory Care Center, NY, NY

Activities and Certification:

Certification in Basics of eCTD submissions by FDA

Certification in Video Nystagmography

Certification on Vestibular Rehabilitation from Education Resources NJ

Internship Experience:

Mahatma Gandhi Memorial Medical College, Indore, India October 2002-February 2003

Indian Spinal Injury Center, Delhi, India March 2003-May 2003

Choithram Hospital and Research Center, Indore, India July 2003-September 2003

Internship involved clinical exposure in Physical Therapy in the following disciplines:

Intensive care unit

Out-patient – Neurology, Pediatrics and Orthopedics Departments

Contact this candidate