Justin Sindol Email & Phone Number

Philippines

1. Participates in project teams that may be led by a Principal Regulatory Writer or Associate Principal Regulatory Writer2. Authors documents (such as Clinical Study Protocol and Lay Summary) per client specifications, templates, style guides, and other guidance documents3. Provides support to the clients that are new to the medical writing 4. Acts as a client point of contact to the project, maintaining collaborative, proactive, and effective communication with both client and internal teams5. Ushers documents through the review process, conducting/participating in client resolution meetings, completing appropriate preparation documents, and compiling appropriate follow-up responses6. Manages the budget for a project or a task within a project, understanding and adhering to the constraints of budgets and tasks as provided in the contract7. Participates in project-related meetings and teleconferences, such as kick-off meetings and comment-resolution meetings8. Supports back-end processes from the development of client contract to the creation of invoice for the client9. Mentors new writers and participates in the planning and implementation of their career development

Philippines

1. Led at least 3 projects from different clients with supports from junior writers as mentees2. Authored clinical, safety, and lay summary documents that adhere to client specifications, templates, style guides, and other guiding documents.3. Provided clinical review of patient narratives and acted as subject matter expert to clients who are starting to write clinical documents4. Ushered documents through the review process up to approval and moderated comment resolution meeting every review process5. Maintained collaborative, proactive, and effective communication with both client and internal teams, including project budget discussion

Philippines

1. Participates on project teams that may be led by a Principal Regulatory Writer, Associate Regulatory Writer, or Senior Regulatory Writer2. Authors documents per client specifications, templates, style guides, and other guidance documents3. Provides clinical review of patient narratives and other documents4. Ushers documents through the review process and conducts comment resolution meetings5. Maintains collaborative, proactive, and effective communication with both client and internal teams6. Participates in project-related meetings and teleconferences

Taguig, Philippines

1. Reviewed and processed adverse event report with hight accuracy percentage. 2. Produced a concise, accurate, and precise case narratives. 3. Performed correct coding of medical diseases, adverse events, and drugs based on project's specific coding conventions.4. Maintained effective safety databases entry guidelines, including accurate entry of data and assurance of quality data through quality control process.

1. Performed laboratory testing, and analysis on different antibiotic products, including confirmatory testing of out-of-specification samples that adheres to quality assurance through out the testing process.2. Gathered data and created report of samples analyzed that was within quality and time.3. Drafted and authorized section's standard operating procedures, including equipment manuals, testing procedures, and method validation. 4. Produced CAPA as answer for internal and external audit findings.5. Maintained logbooks and databases of equipments, instruments, samples tested, as well as training file of all the associates.6. Conducted calibrations of equipments and glasswares as a preventive maintenance. 7. Appeared in equipment and software or program demonstrations.8. Received and checked batch notification applications of antibiotic products. 9. Conducted temperature monitoring of equipment room, standard storage, sample storage. 10. Provided agenda, minutes, and action points of the meetings.

1. Ensured compliance with the existing requirements of FDA Philippines2. Provided counselling with customers on making decisions in buying the best supplements3. Overseen monthly product inventory

Master Of Statistics, Industrial Statistics

Bs Pharmacy, Hospital Pharmacy