Duration: 12+ months
Location: Lansdale, PA
Job 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 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 in order 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 & Co. Resources Managed (budget and FTEs).
- This is an individual contributor. Primary Responsibilities 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 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.
Company:Integrated Resources, IncLocation:Lansdale - Pennsylvania - United StatesJob Types:ContractPost Date:October 25, 2021Valid Through:November 24, 2021