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(Sr) Project Manager - (FSP) Patient Access Programs

Pharmaceutical Product Development (PPD)

NC-Wilmingto

Submission for the position: (Sr) Project Manager - (FSP) Patient Access Programs - (Job Number: 182920)

Objectives: Lead operational implementation and ongoing execution of assigned R&D Patient Access programs and initiatives Serve as the lead for assigned program(s) interfacing with internal stakeholders in Global, Regional, and Local offices as well as external vendors to ensure efficient and compliant delivery of assigned R&D Patient Access programs, and quickly resolve issues when raised. Manage program level internal training, tracking, and reporting supporting patient access initiatives.

Accountabilities: Drive the execution of assigned R&D Patient Access Expanded Access Programs (including program implementation, maintenance, and closure), ensure they meet overall objectives and achieve results for the benefit of patients. Monitor assigned program(s) operational performance against established metrics, escalating issues as needed and identifying areas for process improvement Manage relationships with key external partners and vendors on behalf of R&D Patient Access Collaborate with internal stakeholders for assigned programs, including but not limited to Medical Affairs, Regulatory, Quality, Pharmacovigilance, Legal, Supply Chain, and applicable Business Units to launch and manage programs and design solutions to ad hoc issues, ensuring program alignment to stakeholder needs. Develop product demand plan and budget for assigned program(s), including tracking and periodic review and updates to ensure quality and timely delivery of efficient programs Provide regular and ad hoc program reports to internal stakeholders, including updates for the PSMF, PSURs and PBRERs

Objectives: Lead operational implementation and ongoing execution of assigned R&D Patient Access programs and initiatives Serve as the lead for assigned program(s) interfacing with internal stakeholders in Global, Regional, and Local offices as well as external vendors to ensure efficient and compliant delivery of assigned R&D Patient Access programs, and quickly resolve issues when raised. Manage program level internal training, tracking, and reporting supporting patient access initiatives.

Accountabilities: Drive the execution of assigned R&D Patient Access Expanded Access Programs (including program implementation, maintenance, and closure), ensure they meet overall objectives and achieve results for the benefit of patients. Monitor assigned program(s) operational performance against established metrics, escalating issues as needed and identifying areas for process improvement Manage relationships with key external partners and vendors on behalf of R&D Patient Access Collaborate with internal stakeholders for assigned programs, including but not limited to Medical Affairs, Regulatory, Quality, Pharmacovigilance, Legal, Supply Chain, and applicable Business Units to launch and manage programs and design solutions to ad hoc issues, ensuring program alignment to stakeholder needs. Develop product demand plan and budget for assigned program(s), including tracking and periodic review and updates to ensure quality and timely delivery of efficient programs Provide regular and ad hoc program reports to internal stakeholders, including updates for the PSMF, PSURs and PBRERs Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Knowledge of the key principles of cross functional project management (Time, Quality, Cost).

Solid financial acumen.

Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.

Displays effective communication skills (listening, oral, written) and can communicate in English language (oral,written).

Sound interpersonal skills, is flexible and adapts to changing situations.Has the ability to persuade, convince, and influence or impress others.

Is organised, proficient at multi-tasking with good attention to detail.

Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate.

Able to delegate, effectively prioritizes own and workload of project team members

Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Possesses cross cultural awareness and is able to adapt appropriately.

Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology.

Has experience with leading, liaising and coordinating cross-functional project teams.

Has knowledge/understanding of clinical development guidelines and directivesWorking Environment:

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Education and Experience:

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training, & experience.

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills and Abilities:

Knowledge of the key principles of cross functional project management (Time, Quality, Cost).

Solid financial acumen.

Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen.

Displays effective communication skills (listening, oral, written) and can communicate in English language (oral,written).

Sound interpersonal skills, is flexible and adapts to changing situations.Has the ability to persuade, convince, and influence or impress others.

Is organised, proficient at multi-tasking with good attention to detail.

Able to lead, motivate and coordinate teams. Coach/mentor team members as appropriate.

Able to delegate, effectively prioritizes own and workload of project team members

Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc.

Possesses cross cultural awareness and is able to adapt appropriately.

Has an understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology.

Has experience with leading, liaising and coordinating cross-functional project teams.

Has knowledge/understanding of clinical development guidelines and directivesWorking Environment:

PPD values the health and well being of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Able to work in non-traditional work environments.

Able to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.

This role requires independent travel up to 15%, inclusive of traveling in automobiles, airplanes, and trains.

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.

Submission for the position: (Sr) Project Manager - (FSP) Patient Access Programs - (Job Number: 182920)

Job posted: 2021-01-22

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