Rosalind Mae Denopol
Project Lead - Medical Writer/ Cross-Functional Auditor
Pasig City, Metro Manila
Summary
Skilled Clinical Research Specialist bringing expertise in operations and project management. Helps achieve goals by coordinating resources, schedules and team members to meet demands. Seeks every opportunity to improve operations and team performance. Adept at quickly learning new technologies and processes for driving success. Proven track record of successfully managing multiple projects and developing innovative solutions.
Overview
17
17
years of professional experience
5
5
years of post-secondary education
Work History
Senior Specialist – Medical Writer, Medical Device
ClinChoice, Inc.
Pasig City, Metro Manila, Philippines
01.2023 - Current
- Identified areas in need of critical improvement and implemented strategies to achieve targets.
- Supported department leadership in implementing new policies, procedures and controls.
- Guided less experienced staff through processes such as [Type] and [Type] as singular point of contact for high-level needs.
- Oversaw work of junior personnel, helping to motivate strong performance and improve overall knowledge with focus on mentoring and coaching.
- Offered coaching and resources to help program participants maintain progress and achieve goals.
- Verified accuracy and effectiveness of reporting processes, effectively using various tools (e.g., Dashboards, Trackers, QC Review Checklist Forms) to track and model data for management review.
- Modeled effective and constructive communication behaviors between department heads, low-level staff and senior leaders to improve cross-functional collaboration.
- Led projects by coordinating schedules, organizing resources and delegating work to meet deliverable and timeline requirements.
- Produced quality standards, checklists, report templates, and processes.
- Planned, executed, and controlled assigned projects, ensuring work performed complied with contractual requirements.
- Partnered with project team members to identify and quickly address problems.
- Met with line manager biweekly to provide detailed project report and milestone updates.
- Conducted independent technical reviews of current processes and records to proactively identify and correct process and system issues.
- Drove change through quality-oriented strategies to help operations accomplish ambitious short- and long-term goals.
- Developed and trained junior team members by leveraging industry experience to achieve optimal project strategy.
- Updated customers and senior leaders on progress and roadblocks.
- Adjusted project plans to account for dynamic targets, staffing changes, and operational specifications.
- Interpreted clients' needs and introduced services to fit specific requirements.
- Built and managed relationships with key clients and partners to drive growth.
- Developed and implemented systems to track customer feedback and satisfaction.
Specialist – Medical Writer, Medical Device
ClinChoice, Inc.
Pasig City, Metro Manila, Philippines
10.2018 - 12.2022
- Assists in developing and review of clinical study documents: clinical study reports (CSR), study protocols/synopses, informed consent (IC), investigator’s brochure (IB), safety management plan, and safety reports (PBRERs, DSURs, PADERS, etc.)
- Conducts literature scans/searches and review for summaries and reports
- Proactively incorporates team input and comments into edits and revisions
- Performs and completes quality review and verification vs source data
- Completes project/workstream/ClinChoice specific work instructions (WI), process guidelines, SOP trainings as per identified schedule
- Contributes knowledge on diverse topics within the Medical Device arena
- Streamlines the clinical research writing approach to ensure that clinical and epidemiologic data are presented coherently
- Effectively organize and delegate work where applicable to complete the assigned tasks to meet deadlines
- Mentor and bestow domain knowledge to the team
- Ensure the assigned tasks are delivered 100% on time or before, as per project SLA
- Demonstrate Quality of Work & Commitment through excellence in work, ensure correctness and completeness in deliverables with minimum OR no re-work
- Be able to independently perform tasks with minimal guidance & supervision
- Functionally review the team’s work for accuracy and compliance where applicable
- Ensure proper planning of the deliverable and foresee any risks that are likely to arise
- Ensure error free and 100% quality in assigned deliverables
- Ensure that all assigned goals [e.g
- Utilization and efficiency] are met as per set standards for the performance year
- Responsible to ensure training compliance and timesheet compliance
- Conduct functional training for the team members
- Support in the functional capability development of junior members
- Be aware of and comply with the QMS/ ISMS & PIMS Policy
- Report any potential or actual Security Breaches to the regional and/or global DPO & Security Incidents to CISO/ applicable distribution list
- Contribute towards the achievement of Quality Objectives
- Point of contact (POC) for Medical Writing for Clinical Research (MD-CR)
- Performs project team leadership activities (time and resource management, project and trend reporting, project performance reviews, training of junior peers)
- Participates in internal audits as cross-functional internal auditor for ClinChoice supporting QA
Senior Executive - CCDS Specialist
ClinChoice, Inc.
Pasig City, Metro Manila, Philippines
08.2015 - 10.2018
- Support Medical Affairs/ Medical Information
- Evaluation of medical literature, support to call center, development of verbal and written materials and communication with HCPs, development of Company Core Data Sheets (CCDS), development and execution of scientific education and training, and vendor and crisis management
- Assist with new product development, KOL engagement, scientific strategy, claims development and substantiation and scientific publications, medical writing, IIS
- Secondary Responsibilities
- Provides therapeutic area (e.g., Pain, Digestive Health, Smoking Cessation or UR/Allergy) knowledge support and clarification of science as needed
- Conducts and evaluates literature searches and analyze scientific literature
- Creates standard language for product information reference manuals, including FAQ’s for new product launches, media issues and publications
- Provides medical support in reviewing the printed packaging components, labeling and compendia
- Collaborates with physicians as the medical representative on cross functional teams (copy clearance committees) to both marketed products and support to new marketed concepts for promotional and non-promotional pieces to ensure medical/scientific accuracy
- Participates in creation of medical training materials and programs that are used to support initial and ongoing training for new employees
- Trains employees who require in-depth scientific/ medical knowledge of relevant products/ therapeutic areas
- Creates and develops strategically targeted information in response to published scientific literature, news media releases, marketing initiatives, product recalls, or new or highly publicized medical discoveries or information
- Contributes to research activities via scientific publications
- Attends key medical/ pharmacy professional meeting to gain knowledge related to therapeutic areas in relevant markets
- Conducts research on educational and technical materials in support of local and regional speakers upon solicited request
- Assists in generating basic periodic or aggregate safety reports, regulatory submissions, PSURs, annual reports, CCDS
- Supports IIS studies including correspondence with investigators, researching the investigator site and facilitating review and approval of IIS proposals.
- Demonstrated proficient leadership skills to motivate employees and build competent teams.
- Established performance goals for department and provided methods for reaching milestones.
Clinical Review Specialist
Pharmaceutical Product Development (PPD), Inc
Manila
09.2014 - 03.2015
- Reviews patient data in accordance with the Clinical Listings Review Plain in the DVM
- Identifies data issues and works with PPD team and study sites to resolve
- Ensures data accuracy according to departmental operating procedures
- Ensures applicable data review activities are conducted accurately, and all related deliverables are completed to quality expectations, within budget and on time
- Provides support, guidance, and direction on clinical data review to the CDM project team
Regulatory Affairs Associate
Integrity Medical Device Philippines, Inc
Cebu
11.2013 - 08.2014
- Initial registration, renewal of product licenses in an efficient and timely manner
- Report work plans weekly to the immediate supervisor
- Implement regulatory strategies to meet timelines set for product registrations, renewals, anti-infective – batching, and other FDA / PDEA / IPO related requirements, DDB, DOH
- Organize all digital and physical data from manufacturers & distributors
- Establish company packaging and delivery standards
- Manage inventory
- Quality check of products and stocks
- Proper implementation of the Suspected Adverse Drug Reaction Form
- Conducts technical training relative to product knowledge to medical representative
- Oncology Clinical Research
Oncology Clinical Research Coordinator
Cebu Cancer Institute, Perpetual Succour Hospital
Cebu
03.2006 - 08.2014
- Analyzes and resolves discrepancies in data validation or other reports with in specified timelines
- Complies and assures adherence to ICH-Good Clinical Practice, SOPs, and Study Protocols
- Reviews data listing for consistency and accuracy of data
- Ensures complete source data documentation and monitors investigational drug compliance
- Documents all relevant Adverse events and Serious adverse events
- Submits Serious Adverse Event Forms and Adverse Event Forms to the Ethics Review Board
- Arranges study visits and provides instructions
- Coordinates with the Patient, Sponsor and the Clinical Research Team
- Updates Case Report Form entry completion logs as required
- Completes Case Report Forms or Electronic Case Report Form
- Performs data verification activities
- Assists with preparation of protocols, informed consents, amendments and other necessary documents for review by the IERB and sponsor
Oncology Clinical Pharmacist
Cebu Cancer Institute, Perpetual Succour Hospital
Cebu
03.2006 - 08.2014
- Provides care for patients in all phases of diagnosis and treatment
- Collaborates closely with the Doctor, Nurse practitioner, Physical therapist, Occupational therapist, Dietitian, Social worker, Compounding pharmacist, and Chaplain to provide comprehensive, individualized care during the treatment
- Provides expert pharmacy care to maximize health, to enhance quality of life and to relieve suffering
- Provides education and support to patients and their families
- Assists and supports patients during diagnostic and therapeutic procedures, closely monitors patients for changes in health status, and coordinates discharge planning
- Maintains good relationship with hospital personnel and public
- Dispenses Oncology Chemotherapy products
- Applies Medication Adherence and Pharmacotherapy (ie
- Dose Computation & Drug Interactions)
- Conducts Pharmacy consultation
Education
Diploma in Pharmaceutical Medicine And Management
Ateneo De Manila University-Salcedo Campus
HV Dela Costa Street, Salcedo Village, Makati City 04.2018 - 09.2018
Bachelor of Science - Clinical Pharmaceutical Sciences
University of San Carlos
Cebu City, Cebu, Philippines 06.2010 - 06.2011
Bachelor of Science - Major in Pharmacy
University of San Carlos
Cebu City, Cebu, Philippines 06.2001 - 03.2005
Skills
undefined
Affiliations
Philippine College of Pharmaceutical Medicine
Philippine Pharmaceutical Association
Timeline
Senior Specialist – Medical Writer, Medical Device
ClinChoice, Inc.
01.2023 - Current
Specialist – Medical Writer, Medical Device
ClinChoice, Inc.
10.2018 - 12.2022
Diploma in Pharmaceutical Medicine And Management
Ateneo De Manila University-Salcedo Campus
04.2018 - 09.2018
Senior Executive - CCDS Specialist
ClinChoice, Inc.
08.2015 - 10.2018
Clinical Review Specialist
Pharmaceutical Product Development (PPD), Inc
09.2014 - 03.2015
Regulatory Affairs Associate
Integrity Medical Device Philippines, Inc
11.2013 - 08.2014
Bachelor of Science - Clinical Pharmaceutical Sciences
University of San Carlos
06.2010 - 06.2011
Oncology Clinical Research Coordinator
Cebu Cancer Institute, Perpetual Succour Hospital
03.2006 - 08.2014
Oncology Clinical Pharmacist
Cebu Cancer Institute, Perpetual Succour Hospital
03.2006 - 08.2014
Bachelor of Science - Major in Pharmacy
University of San Carlos
06.2001 - 03.2005
Similar Profiles
CATHERINE JOY AGUSTIN-ENCISOCATHERINE JOY AGUSTIN-ENCISO
Safety Surveillance Physician at ClinChoice, Inc.Safety Surveillance Physician at ClinChoice, Inc.
Deanna OganesianDeanna Oganesian
Clinical Technical Writer+Editor, Medical Affairs at ClinChoice Inc.Clinical Technical Writer+Editor, Medical Affairs at ClinChoice Inc.
SHEENA BELINDA TABORA GAVINOSHEENA BELINDA TABORA GAVINO
Safety Surveillance Physician (Team Lead) at ClinChoice Inc.Safety Surveillance Physician (Team Lead) at ClinChoice Inc.
Elaine BoylesElaine Boyles
Marketing Supervisor at Ideal Focus Inc.Marketing Supervisor at Ideal Focus Inc.
Agatha Hyacinth HonoratoAgatha Hyacinth Honorato
OPERATIONS SUPPORT BET at WANFANG TECHNOLOGY INC.OPERATIONS SUPPORT BET at WANFANG TECHNOLOGY INC.