Job Title: Lead- Patient Support Program

Location: Malaysia

Department: Project Management- Operations

Report to: Sr. Project Manager / Group Head

Job Overview:

Patient support Program (PSP) lead would be responsible to handle the team of program executives working for various PSPs. Client interface for project related requirements. Would be responsible to work with business development team in SEA region to generate leads for various PSPs. Ability to build contacts with hospitals and understand the need of PSP among HCPs and Patients. Knowledge about the drugs and prior experience in handling the drugs, handling PSPs would be an added advantage.

Key Responsibilities:

o Ability to manage the PSPs effectively. Client management. Handling queries from hospitals and patients

o Ability to handle the team of program executives working for PSPs across SEA region

The candidate should be willing to travel across SEA countries to generate leads from various pharma clients.

o The candidate should collaborate and assist business development team in generating and converting PSP leads

o The candidate should be willing to explore various types of PSPs that are executed in Singapore and Malaysia

o Should have good English/ Mandarin language communication skills and should be able to communicate through telephone and emails fluently.

o Willing to work in general shift. 9:30 AM to 6:30 PM;

Monday to Friday SG Time

o Develop professional relationships; build advocacy and scientific partnerships with HCPs, across various hospitals

o Maintain thorough and up-to-date knowledge of current and emerging therapies, including clinical information and competitive product information

Please submit your resume to usha.b@bioquestglobal.com

Manager, Project Management - Assen, Netherlands - Hybrid

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

As we continue to grow, we are seeking Manager of Project Management to join our team at the LC-MS/MS department of the Bioanalytical Laboratory and help drive our success to new heights. You will be based at our Assen site - on site for 60% of the week with home based working an option for the other 40%.

The Role

As the Manager of Project Management, you will be responsible for the overall direction of a team of project managers and support staff. Next to people management, your primary focus will be to ensure consistency with corporate strategy, processes across projects, and exceptional customer satisfaction. Your role involves providing day-to-day technical oversight to the Project Management team, inspiring and guiding your team, and playing a pivotal role in the successful execution of regionally assigned programs and projects.

What you will be doing:

• Lead and mentor the project management team consisting of Project Managers and support staff, fostering a culture of excellence, collaboration, and continuous improvement.
• Direct and provide day-to-day technical oversight to the Project Managers and support staff, ensuring study execution and reporting meet client expectations.
• Develop and communicate a clear vision for the department and the organization, inspiring team members to work towards common goals.
• Lead or participate in continuous improvement initiatives with regards to regulations, training and quality, and maintain integrated processes within Project Management.
• Accountability: Accountable for the overall direction, coordination, implementation, execution, control, and successful completion of all regionally assigned programs and projects.
• Partnership: Serve as a key point of contact for internal and external stakeholders, fostering strong relationships and ensuring customer satisfaction.

Your Profile:

• Master's degree in a related field; advanced degree preferred.
• Proven in-depth experience working in a clinical laboratory within a CRO, Biopharmaceutical company, or related organization.
• Demonstrated expertise as a Project Manager.
• Strong leadership skills with prior experience in mentoring, supervising, or leading teams.
• Excellent communication and presentation abilities, both verbal and written.
• Ability to manage multiple projects concurrently while ensuring adherence to timelines and quality standards.
• Detail-oriented with a proactive approach to problem-solving and decision-making.
• Passionate about advancing healthcare and contributing to the success of clinical research.

#LI-DK2

#LI-Hybrid

What ICON can offer you:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click to apply

We are hiring for Multiple Positions across various departments and locations. If you're looking for a new opportunity, don't miss our walk-in interview event!

Candidates from CDMO, API, Intermediate and multi-products manufacturing industry are preferred.

Work Locations: Atali, Vapi, Dombivli, Nerul and Tarapur

Walk-in Interview date and location: 1st Feb 2025 at Bharuch

Attend the interview, get selected, and receive your formal job offer letter on the same day

Please Carry the Following Documents:

* Updated resume

* Aadhar card and PAN card

* Last 3 months salary slip

* Latest CTC annexure

* Education documents

Walk-in interview Venue and Time (10:00AM-5:00PM)

RE:GEN:TA Central Harimangla,

ABC Circle, Old NH-8. Bholav, Bharuch, Gujarat, India - 392 015

M: +91 82380 99188 T: +91 2642-254500

F: +91 2642-254501

Project Management in the Pharmaceutical Industry

Project management in the pharmaceutical industry involves planning, executing, and managing resources to achieve specific goals within scope, time, and budget constraints. It ensures the successful development, production, and distribution of pharmaceutical products while meeting regulatory and quality requirements.

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Key Areas of Project Management

1. Drug Development Projects

   • Managing preclinical and clinical trials.
   • Overseeing formulation and process development.
   • Coordinating regulatory submissions (e.g., IND, NDA, ANDA).

2. Manufacturing Projects

   • Scaling up production processes.
   • Validating equipment and processes.
   • Ensuring compliance with GMP and regulatory standards.

3. Quality Improvement Projects

   • Implementing quality systems (e.g., CAPA, risk management).
   • Enhancing manufacturing efficiency and product quality.

4. Technology Transfer Projects

   • Transitioning production from R&D to manufacturing.
   • Collaborating across departments to ensure knowledge transfer.

5. Regulatory and Compliance Projects

   • Preparing for regulatory inspections.
   • Managing updates to comply with new guidelines.

6. Market Launch Projects

   • Coordinating activities for product approval and launch.
   • Collaborating with marketing and sales teams.

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Key Phases in Pharmaceutical Project Management

1. Initiation

   • Define project goals, scope, stakeholders, and deliverables.
   • Conduct feasibility studies and risk assessments.

2. Planning

   • Develop detailed project plans, including timelines, budgets, and resource allocation.
   • Create a quality management plan.
   • Establish communication and risk mitigation strategies.

3. Execution

   • Coordinate cross-functional teams (e.g., R&D, QA, QC, Regulatory, Manufacturing).
   • Monitor progress using tools like Gantt charts or project management software.

4. Monitoring and Control

   • Track key performance indicators (KPIs).
   • Identify and address deviations from the plan.
   • Conduct regular status meetings and provide updates.

5. Closure

   • Review project deliverables and document lessons learned.
   • Archive project records and transfer knowledge.

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Key Skills for Pharmaceutical Project Managers

1. Technical Knowledge

   • Understanding pharmaceutical processes, regulatory requirements, and quality standards.

2. Leadership and Communication

   • Managing diverse teams and ensuring clear communication among stakeholders.

3. Time and Budget Management

   • Delivering projects within deadlines and financial constraints.

4. Problem-Solving and Decision-Making

   • Addressing challenges, such as delays in clinical trials or regulatory hurdles.

5. Proficiency with Tools

   • Familiarity with project management software like MS Project, Jira, or Trello.

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Challenges in Pharmaceutical Project Management

1. Regulatory Complexity

   • Navigating global regulations and submission requirements.

2. Uncertainty in Drug Development

   • Managing risks and uncertainties in clinical trials or production.

3. Resource Management

   • Allocating resources effectively among competing priorities.

4. Time-Consuming Processes

   • Dealing with long timelines for product development and approval.

5. Cost Constraints

   • Balancing innovation with cost control.

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Benefits of Effective Project Management

• Accelerated time-to-market for new products.
• Enhanced compliance with regulatory standards.
• Improved collaboration across departments.
• Efficient use of resources and reduced costs.
• Higher product quality and customer satisfaction.

Gland Pharma Limited is hiring for Project Management department.

Project Management R&D

Qualification: M.Sc., B. Pharma / M. Pharma / MBA

Experience: 3-5 Years

Job Location: Dundigal, Hyderabad.

Job Roles:

1. Responsible for end-end Project Management activities, proactively contributing in project planning, execution, tracking, monitoring, troubleshooting, and facilitating till project completion.

2. To lead CFT meetings to track and monitor the project progress and to deliver within the stipulated timelines etc.....

Interested candidates can share their profile to eswarreddy.ravi@glandpharma.com

Position: Project Management Manager

Experience: 10-12 years in pharmaceutical R&D project management; PMP certification preferred

Location: Palava, Navi Mumbai

Reporting to: General Manager

Travel: Not frequent

Responsibilities:

Lead and manage R&D projects for Generics, ensuring milestones are achieved on schedule.

Act as a central point of contact for all stakeholders, driving communication and collaboration between Formulation, Analytical, Manufacturing, Quality, Procurement, and Management teams.

Develop detailed project plans, monitor progress, and adapt strategies as required to address changing priorities or challenges.

Ensure alignment of project activities with regulatory standards for US and other international markets. Maintain detailed documentation for project workflows, timelines, and critical decisions for auditing and reporting purposes.

Track project budgets and ensure optimal utilization of resources while adhering to financial constraints.

Conduct regular project review meetings, presenting updates and insights to the General Manager and senior management team.

Identify potential risks, develop contingency plans, and execute mitigation strategies to ensure project continuity.

Collaborate with the regulatory team to prepare high-quality submission packages for FDA and other global authorities.

Oversee technology transfer activities to manufacturing facilities, ensuring smooth handover from R&D to production.

Provide mentorship and support to project teams, fostering professional growth and a culture of accountability.

Continuously assess and implement best practices in project management to enhance efficiency and outcomes.

Skills and Competencies:

Pharma Knowledge: Thorough understanding of R&D processes for Generic Product Development.

Regulatory Knowledge: Familiarity with FDA and international regulatory guidelines.

Technical Skills: Advanced proficiency in MS Excel, PowerPoint and Dashboard for project tracking and reporting.

Communication: Exceptional verbal and written communication skills to interface effectively with cross-functional teams.

Leadership: Strong ability to motivate and guide teams, driving performance and ensuring accountability.

Analytical Thinking: Expertise in problem-solving, decision-making, and risk assessment.

Organizational Skills: Ability to manage multiple projects and priorities simultaneously.

Qualifications:

Bachelor's or Master's degree in Pharmacy, Pharmaceutical Sciences.

PMP (Project Management Professional) certification is preferred.

Interested candidates can share their profile on reshma.c@encubeethicals.com