Program Manager Position with Clinical / Medical Affairs

PROGRAM MANAGER POSITION WITH CLINICAL / MEDICAL AFFAIRS LANSDALE, PA Starting remote then moving onsite in Lansdale, PA. Project Description:

• Reporting to the Director of R&D Business Systems Clinical/Medical Affairs, the Program Manager Clinical/Medical Affairs Business Systems Oversight is accountable for delivering strategically aligned capabilities that digitally transform clinical and medical affairs.
• This role is accountable for ensuring clinical and medical affairs systems fully support all phases of product development and lifecycle management for the Client's products.
• This role drives strategic activities for clinical and medical affairs business system capabilities in alignment with the Director of Research & Development Business Systems for Clinical/Medical Affairs.
• The role collaborates with many stakeholders and users of the clinical and medical affairs capabilities to plan and execute business system activities.
• Organizational Relationships:
  • This position will report to the Director of Clinical/Medical Affairs Business Systems Oversight within Innovation & Information Management, under the Strategic Research and Development organization of the Client's company.
  • Resources Managed (budget and FTEs) This is an individual contributor.
• The Program Manager Clinical and Medical Affairs Business System Oversight is accountable and responsible for the following activities:
  • Partners with external parties (i.e., vendors) and internal R&D functions.
  • Leads projects and initiatives supporting the long-term vision and strategy for clinical and medical affairs business systems, helping to drive business outcomes.
  • Provides industry expertise and practical knowledge of current and emerging technologies and process approaches within clinical and medical affairs.
  • Ensures high ethical standards and a culture that values honesty, integrity, and transparency.

• Bachelor's degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations areas is required.
• 5+ years of leading clinical and/or medical affairs business system capabilities within a research and development organization.
• Ability to plan and lead global change management to support a phased worldwide rollout, including training, UAT, cut over, and hyper care.
• Risk management/mitigation skill and experience is crucial.
• Flexible and adaptive PM skills to accommodate a fast-paced dynamic environment.
• 3+ years of experience in a regulated research and development environment, preferably in clinical and/or medical affairs.
• Experience with medical information (MI) systems implementations in a life sciences/ medical affairs environment is highly desirable.
• Knowledge of MI processes and procedures is preferred.
• Must have proven track record to be able to think critically, strategically, independently and problem solve.
• Must have a high level of motivation, drive, and demonstration of the Client's leadership values.
• Excellent written and verbal communication skills including the ability to write clearly and concisely.
• Top-notch interpersonal skills in difficult situations.
• Drives change and innovation.
• Demonstrated experience in mapping process flows and identifying process improvements.
• Ability to work seamlessly with all levels of personnel.
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geo cultural collaborations.
• Excellent SharePoint, Excel, and Visio skills.