Pharmavise Corporation

• Lead and deliver GxP-focused consulting engagements, serving as an SME across multiple functions such as Quality, Regulatory, Manufacturing, Engineering, and Clinical Operations. • Develop, review, and optimize Quality Management Systems (QMS) and regulatory frameworks aligned with applicable global standards (FDA, ISO, ICH, EU MDR, MHRA, Health Canada, etc.). • Provide expert guidance on compliance readiness, remediation, and responses to regulatory inspections (FDA 483s, Warning Letters, audit observations). • Design, execute, and oversee validation and qualification programs: Process validation Equipment qualification (IQ/OQ/PQ) Software/CSV (21 CFR Part 11) Cleaning and sterilization validation Computerized systems validation. • Support product development programs, ensuring adherence to design control, risk management, verification/validation, and DHF/technical documentation requirements. • Perform gap assessments, root cause investigations, and CAPA development to address quality and compliance risks. • Serve as an advisor to executive teams and technical leads on regulatory pathways, submission strategies, and lifecycle management. • Provide project leadership and mentoring to junior team members, ensuring structured execution and high-quality deliverables. • Prepare and deliver client-facing reports, technical documentation, strategic recommendations, and training. • Support change management, technology transfer, and scale-up initiatives for manufacturing and operations. • Travel to client sites as needed.

Role Description This is a remote position. From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. - Lead and contribute to cell therapy research and development projects aimed at advancing novel cellular therapies for various diseases and conditions. - Design and optimize cell therapy manufacturing processes, including cell isolation, expansion, differentiation, and characterization. - Develop innovative strategies to enhance the efficacy, safety, and scalability of cell therapy products. - Collaborate cross-functionally with research, translational, clinical, and regulatory teams to advance cell therapy programs from preclinical development through to clinical trials and commercialization. - Stay abreast of emerging technologies, scientific advancements, and regulatory requirements in the field of cell therapy. - Contribute to the preparation and review of regulatory submissions, including INDs, BLAs, and marketing authorization applications. - Mentor and provide guidance to junior staff members and collaborators working on cell therapy projects. Qualifications - PhD or equivalent degree in cell biology, immunology, regenerative medicine, or related field. - Minimum of 5 years of experience in cell therapy research and development within the biotechnology or pharmaceutical industry. - Strong expertise in cell culture techniques, cell engineering, and cell-based assays. - Experience with cell therapy manufacturing processes, including GMP requirements and quality control/assurance. - Knowledge of regulatory requirements and guidelines governing cell therapy product development (e.g., FDA, EMA). - Excellent analytical and problem-solving skills, with the ability to design and interpret complex experiments. - Effective communication and collaboration skills, with the ability to work in a fast-paced, team-oriented environment. - Leadership experience and a track record of successfully leading cell therapy projects preferred but not required. Benefits - Competitive compensation packages. - Comprehensive benefits for full-time positions. - Flexible scheduling options for per diem roles. Company Description Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality. EEO Employer: Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com. Follow us in LinkedIn for more company updates and opportunities.

Role Description This is a remote position. We are seeking experienced Clinical Research Associates (CRAs) to provide surge capacity support for ongoing clinical research projects. This role focuses on study maintenance and closeout activities, ensuring efficient project execution. The CRA will serve as a primary point of contact for study teams and external partners, supporting essential clinical operations without direct involvement in study startup activities. - Oversee study-level project management tasks, including study maintenance, data lock, closeout, document review, and budget monitoring. - Act as the primary liaison between internal study teams and external third-party organizations (TPOs). - Track and monitor safety, biomarker, pharmacokinetic (PK), anti-drug antibody (ADA) samples, imaging data, and connected device data. - Manage and track clinical queries to ensure timely resolution. - Collaborate with internal teams to align clinical research processes and operational strategies. - Coordinate with business partners and TPOs to facilitate data delivery and ensure compliance with study requirements. Qualifications - Bachelor’s degree in a relevant field. - 6+ years of experience in clinical research or a related industry. - Experience as a Clinical Research Associate, Clinical Research Coordinator, or Clinical Research Assistant. - 3+ years of experience in project management or a related role. - Prior experience in pharmaceutical, diagnostics, or CRO environments. - Strong organizational skills with attention to detail. - Ability to effectively communicate with diverse stakeholders. - Proficiency in Microsoft Excel for data tracking and reporting. - Experience with clinical trial management tools such as Medidata RAVE, Veeva Vault, Oracle InForm, or similar platforms. - Familiarity with electronic Trial Master File (eTMF) systems, query management tools, and safety reporting databases. - Working knowledge of GCP (Good Clinical Practice) guidelines and regulatory compliance requirements. Benefits - Paid holidays. - Paid Time Off (PTO) policy. - Medical insurance to ensure our team members have the flexibility and coverage they need. E-Verify Participation Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify .

Role Description This is a remote position. We are excited to announce an opportunity for a talented and experienced professional to join our team as a Consultant/Biologics. Below is a detailed job description outlining the responsibilities, qualifications, and expectations for this individual contributor role: Responsibilities: - Provide expert consulting services and strategic advice to clients in the biopharmaceutical industry, with a focus on biologics development, manufacturing, and regulatory affairs. - Collaborate closely with clients to understand their needs, challenges, and objectives, and develop tailored solutions to address specific business and regulatory requirements. - Conduct assessments and gap analyses of clients' biologics programs, processes, and operations to identify areas for improvement and optimization. - Develop and implement strategic plans and initiatives to support clients' biologics development and commercialization efforts, including regulatory strategy, CMC (Chemistry, Manufacturing, and Controls) strategy, and lifecycle management. - Provide guidance and support on regulatory submissions for biologic products, including INDs, BLAs, MAAs, variations, and post-approval supplements. - Review and interpret regulatory guidelines, requirements, and industry best practices related to biologics development, manufacturing, and compliance. - Support clients in preparing for regulatory interactions and inspections, including FDA meetings, regulatory agency audits, and responses to regulatory inquiries. - Stay abreast of emerging trends, advancements, and regulatory changes in the biologics industry and provide insights and recommendations to clients. Qualifications - Advanced degree (PhD, MS, or equivalent) in a scientific or engineering discipline, preferably in biochemistry, biotechnology, pharmaceutical sciences, or related field. - Minimum of 5 years of experience in the biopharmaceutical industry, with a focus on biologics development, manufacturing, or regulatory affairs. - Strong expertise in biologics development and manufacturing processes, including upstream and downstream processing, analytical methods, and characterization techniques. - Deep understanding of global regulatory requirements and guidelines applicable to biologic products, including FDA, EMA, and ICH regulations. - Proven track record of successful consulting engagements or project management in the biopharmaceutical industry, with demonstrated ability to deliver results and drive client satisfaction. - Excellent communication and interpersonal skills, with the ability to effectively engage with clients at all levels of the organization. - Strong analytical and problem-solving abilities, with the ability to assess complex challenges and develop innovative solutions. - Willingness to travel as needed to meet client requirements. Benefits - Competitive compensation packages are available. - Be part of our network of Subject Matter Experts. EEO Employer Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com . Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality. Follow us on LinkedIn for more company updates and opportunities.

• Generate and send invoices to clients via SAP Ariba and QuickBooks • Review and approve invoices from internal and external contractors • Execute accurate and timely processing of payroll on Wise and QuickBooks • Oversee invoicing, collections, and payments to vendors, maintaining accurate records and accounts receivable/payable • Document financial transactions by entering account information • Support onboarding and offboarding activities for new hires • Monitor team attendance and time logs • Cross-check attendance with invoices • Create and send invoices via QuickBooks • Set up, monitor, and manage bills in QuickBooks • Conduct monthly reconciliation for five accounts in QuickBooks • Manage the setup of new employees in QuickBooks for onboarding • Prepare, analyze, and present monthly reconciliation reports and financial statements, including profit and loss statements, balance sheets, and cash flow statements • Perform monthly categorizations for five accounts • Conduct balance sheet and profit & loss reconciliations • Review and approve expenses • Manage the benefits and Paid Time Off (PTO) for employees • Address employee inquiries related to payroll, benefits, and PTO • Assist employees with any concerns or issues they have regarding their benefits, compensation, or attendance • Ensure employees are well-informed of their benefits, entitlements, and company policies • Provide guidance and resolve issues in a timely and professional manner • Manage tax-related activities, including the preparation and filing of USA 1040 and 1120S and ensuring adherence to tax regulations

• Lead and manage cross-functional projects within pharmaceutical, biotechnology, and/or medical device environments • Develop and maintain project plans, timelines, budgets, risk registers, and status reports • Coordinate project activities across Quality, Regulatory, Engineering, Validation, Manufacturing, Clinical, and Supply Chain teams • Facilitate stakeholder meetings and communicate project updates to client leadership and internal teams • Identify project risks, issues, and mitigation strategies to ensure successful project execution • Support project governance, resource planning, prioritization, and execution activities • Ensure projects align with applicable GxP, FDA, ISO, and industry compliance requirements • Drive accountability, action item tracking, and project deliverables across multiple stakeholders • Support continuous improvement and operational excellence initiatives • Maintain strong client relationships and represent Pharmavise professionally in client-facing environments.

Role Description We have an exciting opportunity for a Talent Acquisition Specialist. Pharmavise is seeking a highly driven, communication-focused Talent Acquisition Specialist to support recruitment activities within the life sciences consulting space. This role is responsible for sourcing, engaging, screening, interviewing, and advancing qualified candidates through the recruitment process. The ideal candidate thrives in a fast-paced environment, is confident in phone-based candidate engagement, and can manage multiple talent pipelines while maintaining accurate, timely records in recruiting systems. Responsibilities and Job Requirements - Candidate Sourcing & Outreach - Execute targeted outreach to candidates and consultants through: - LinkedIn Recruiter and other sourcing platforms - Email campaigns and follow-up sequences - Phone calls and text messaging, where appropriate - Referrals, job boards, talent databases, and professional networks - Maintain consistent follow-up with candidates to maximize engagement, confirm availability, and keep qualified professionals warm for future opportunities. - Build and maintain pipelines of qualified professionals for current and anticipated client needs. - Candidate Screening & Interview Coordination - Conduct initial candidate screens to evaluate: - Relevant technical experience and qualifications - Industry, functional, and regulatory experience - Availability, work authorization, location, compensation expectations, and work preferences - Communication skills, consulting background, and alignment with client requirements - Schedule and coordinate interviews between qualified candidates, Pharmavise recruiters, hiring managers, and client stakeholders. - Prepare candidate notes, summaries, and supporting documentation for internal review and client submission. - Candidate Pipeline Management - Manage candidate movement through the recruiting process, including: - Sourcing and outreach - Initial screening - Interview coordination - Assessment coordination - Candidate follow-up - Submission preparation - Offer and onboarding support - Ensure candidates receive timely communication throughout the recruitment process and maintain a professional, positive candidate experience. - Recruitment Coordination & Team Support - Partner closely with recruiters, account managers, and hiring stakeholders to clarify job requirements, candidate priorities, and submission expectations. - Assist with preparing candidate summaries, interview preparation materials, and submission documentation. - Support onboarding coordination by collecting required candidate documents, confirming start-date readiness, and helping ensure a smooth transition from offer acceptance through assignment start. Tools & Systems - Zoho Recruit or other Applicant Tracking Systems - Microsoft 365: Word, Excel, PowerPoint, Outlook - Microsoft Teams - LinkedIn Recruiter - SignalHire, job boards, resume databases, and similar sourcing tools - Candidate assessment and interview scheduling platforms Qualifications - Bachelor’s degree in Human Resources, Business, Communications, Psychology, or a related field. - Two to three years of experience in recruitment, talent acquisition, staffing, or candidate sourcing. - Experience recruiting for professional, technical, consulting, life sciences, engineering, quality, regulatory, clinical, or healthcare-related roles is preferred. - Strong written and verbal communication skills, including the ability to conduct professional candidate interviews and write clear outreach messaging. - Demonstrated experience with candidate sourcing, screening, interview coordination, and pipeline management. - Experience using an Applicant Tracking System, preferably Zoho Recruit, with strong discipline in documentation and data accuracy. - Highly organized, detail-oriented, and able to manage multiple requisitions and candidate pipelines simultaneously. - Comfortable conducting candidate outreach through email, LinkedIn, phone calls, and other digital communication channels. - Ability to work independently, prioritize urgent hiring needs, and maintain a high level of professionalism and confidentiality. Other Details - Schedule: 10:00 PM to 6:00 AM Philippine Time - Contract: Independent Contractor - 12 months (renewable contract) - Fully Remote

• Execute outbound outreach to: Business Development (BD) leads Candidates and consultants • Utilize multiple channels: Email sequences LinkedIn messaging Phone calls • Schedule: Discovery calls with prospective clients Interviews with qualified candidates • Maintain consistent follow-ups to maximize engagement and response rates • Maintain accurate and real-time updates in: Zoho CRM (leads, opportunities, outreach activity) Zoho Recruit (candidate profiles, interview notes) • Support movement of: BD leads → qualified opportunities Candidates → client submissions • Support pre-sales coordination and internal alignment before client meetings. • Assist in preparing briefing documents prior to discovery calls. • Ensure smooth handoff of: Qualified leads to BDMs Screened candidates to recruiters/hiring manager

• Support pharmaceutical manufacturing operations by applying engineering principles and expertise to optimize processes, equipment, and facilities. • Collaborate with cross-functional teams, including manufacturing, process development, quality assurance, and regulatory affairs, to ensure efficient and compliant manufacturing operations. • Lead or participate in process improvement initiatives, including the identification, evaluation, and implementation of new technologies, equipment, and manufacturing practices. • Conduct risk assessments and develop risk mitigation strategies for manufacturing processes, equipment, and facilities to ensure product quality and compliance with regulatory requirements. • Provide technical support for troubleshooting manufacturing issues, deviations, and investigations, and implement corrective and preventive actions (CAPAs) as needed. • Support the design, installation, qualification, and validation of manufacturing equipment and facilities, including process equipment, utilities, and cleanrooms. • Develop and maintain manufacturing documentation, including standard operating procedures (SOPs), batch records, and equipment qualification/validation documentation. • Stay abreast of industry trends, advancements, and regulatory requirements in pharmaceutical manufacturing and engineering, and apply best practices to drive continuous improvement.

• Lead, mentor, and develop Clinical Trial Managers and other assigned study personnel, fostering a high performance, collaborative team environment. • Oversee end to end operational execution of global clinical trials, ensuring adherence to protocol, GCP, SOPs, and applicable regulatory requirements. • Translate program strategy into operational plans, timelines, and resource needs; ensure cross functional alignment and timely delivery of study milestones. • Oversee development and maintenance of study documentation, including operational plans, study materials, systems, and regulatory submissions. • Manage CROs and external vendors, including selection, contracting, performance oversight, issue escalation, and budget tracking. • Lead proactive risk identification, mitigation planning, and contingency management across assigned studies. • Provide clear, data driven study updates, risk assessments, and recommendations to clinical leadership and governance bodies. • Manage clinical trial budgets, including forecasting, accruals, variance analysis, and financial oversight of vendor contracts. • Build and maintain strong relationships with investigators, clinical sites, and key opinion leaders to support enrollment, engagement, and study success. • Ensure inspection readiness and compliance with internal quality standards, audit findings, and regulatory expectations. • Champion continuous improvement in clinical operations processes, tools, and best practices.