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Associate Director, Medical Communications (Pharmacovigilance)

Pharmaceutical Product Development (PPD)

NC-Morrisville-Morrisville NC 3900 Paramou

Submission for the position: Associate Director, Medical Communications (Pharmacovigilance) - (Job Number: 175683)PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. In Medical Communications, you will begin by joining our Medical Communication Academy and be provided with 4-10 weeks of best-in-class training and support! 

MedCommis truly an exceptional area at PPD. We work to improve patient health by supplying top-quality medical information services to our clients, patients and health care providers. We engage with health care professionals, regulatory agencies and pharmaceutical clients to help them navigate regulatory and compliance requirements around the world.

The Associate Director, Medical Communications is responsible for day to day operations of one or more projects and directs, mentors and supports operations managers and other members of their project teams. Ensures that services are provided in accordance with client and PPD Medical Communications' policies and procedures and contractual agreements. Primary liaison with the client and ensures project report summaries, budget, audit results, staffing decisions and other critical issues are managed appropriately.

As the Associate Director you will: Ensure effective operations for items such as scope of work, contractual issues, changes in staffing levels, and budget negotiation by serving as the primary point of client contact; effective troubleshooting for database issues, phone routing or other items as they effect other departments at PPD, vendors, or other departments at the client; maintaining project knowledge; coordinating and implementing new project operations, and monitoring project processes (QA, compliance, SOPs, regulatory) that will maximize quality and client loyalty. Handle personnel management responsibilities including performance management, salary administration, hiring, employee relations, conflict resolution, and employee development. Ensure quality objectives are met and develops and maintains project SOPs, develops and/or reviews corporate SOPs, and complies with all company policies and procedures including SOPs, protocols, GCPs, and FDA regulations. Monitor billable hours to meet divisional revenue and client budgetary goals, reviews consultant billable hours reports and monitors supervisor billable hours. Verify client invoice amounts and communicates required changes to Medical Communications finance. Participate in capabilities presentations to help secure new business and alert the Director and Business Development team to new business opportunities with existing clients. Reviews and provides operational input on proposals, contracts and/or renewals associated with existing clients. Participate in the development of processes and strategies designed to assist in meeting the above stated goals on a division-wide basis.

Our ideal candidate has experience in a medical information/patient services environment and a strong background in pharmacovigilance! PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.  At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees. In Medical Communications, you will begin by joining our Medical Communication Academy and be provided with 4-10 weeks of best-in-class training and support! 

MedCommis truly an exceptional area at PPD. We work to improve patient health by supplying top-quality medical information services to our clients, patients and health care providers. We engage with health care professionals, regulatory agencies and pharmaceutical clients to help them navigate regulatory and compliance requirements around the world.

The Associate Director, Medical Communications is responsible for day to day operations of one or more projects and directs, mentors and supports operations managers and other members of their project teams. Ensures that services are provided in accordance with client and PPD Medical Communications' policies and procedures and contractual agreements. Primary liaison with the client and ensures project report summaries, budget, audit results, staffing decisions and other critical issues are managed appropriately.

As the Associate Director you will: Ensure effective operations for items such as scope of work, contractual issues, changes in staffing levels, and budget negotiation by serving as the primary point of client contact; effective troubleshooting for database issues, phone routing or other items as they effect other departments at PPD, vendors, or other departments at the client; maintaining project knowledge; coordinating and implementing new project operations, and monitoring project processes (QA, compliance, SOPs, regulatory) that will maximize quality and client loyalty. Handle personnel management responsibilities including performance management, salary administration, hiring, employee relations, conflict resolution, and employee development. Ensure quality objectives are met and develops and maintains project SOPs, develops and/or reviews corporate SOPs, and complies with all company policies and procedures including SOPs, protocols, GCPs, and FDA regulations. Monitor billable hours to meet divisional revenue and client budgetary goals, reviews consultant billable hours reports and monitors supervisor billable hours. Verify client invoice amounts and communicates required changes to Medical Communications finance. Participate in capabilities presentations to help secure new business and alert the Director and Business Development team to new business opportunities with existing clients. Reviews and provides operational input on proposals, contracts and/or renewals associated with existing clients. Participate in the development of processes and strategies designed to assist in meeting the above stated goals on a division-wide basis.

Our ideal candidate has experience in a medical information/patient services environment and a strong background in pharmacovigilance!

Qualifications:

Education and Experience: Previous experience in health care or pharmaceutical industry that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years). Proven leadership skills to include 5 years of management responsibility. Education may be substituted in lieu of some years of experience for advanced degrees such as Pharm.D, Ph.D. MS and MD.

In some cases an equivalency, consisting of a combination of appropriate education, training

and/or directly related experience, will be considered sufficient for an individual to meet the

requirements of the role.

Knowledge, Skills and Abilities: Pharmacovigilance Experience helpful Deep knowledge of pharmacovigilance purpose and practices Strong knowledge of budgeting and forecasting Excellent leadership skills Strong attention to detail and organizational skills Effective verbal and written communication skills Excellent problem solving and analytical skills Excellent time management skills Basic computer skills including Microsoft Office and multi-tasking skills Excellent interpersonal skills Strong decision-making skills Ability to coach and mentor staff Ability to work in a team environment and/or independently as needed

Management Role:

Directs through lower management levels and / or highly skilled specialist employees who exercise

significant latitude and independent judgment. Often heads one or more departments or a large

centralized staff function. In some instances may be responsible for a functional area (as determined by

executive management) and not have subordinate supervisors or employees. May manage employees

across multiple regions.

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment Constant interaction with clients/associates required Must pay constant attention to detail-visual, mental Must be able to multi-task constantly Long, varied hours required occasionally Daily exposure to high pressure, intense concentration Occasional drives to site locations, frequent travels both domestic and international

#LI-PA1

Qualifications:

Education and Experience: Previous experience in health care or pharmaceutical industry that provides the knowledge, skills, and abilities to perform the job (comparable to 10 years). Proven leadership skills to include 5 years of management responsibility. Education may be substituted in lieu of some years of experience for advanced degrees such as Pharm.D, Ph.D. MS and MD.

In some cases an equivalency, consisting of a combination of appropriate education, training

and/or directly related experience, will be considered sufficient for an individual to meet the

requirements of the role.

Knowledge, Skills and Abilities: Pharmacovigilance Experience helpful Deep knowledge of pharmacovigilance purpose and practices Strong knowledge of budgeting and forecasting Excellent leadership skills Strong attention to detail and organizational skills Effective verbal and written communication skills Excellent problem solving and analytical skills Excellent time management skills Basic computer skills including Microsoft Office and multi-tasking skills Excellent interpersonal skills Strong decision-making skills Ability to coach and mentor staff Ability to work in a team environment and/or independently as needed

Management Role:

Directs through lower management levels and / or highly skilled specialist employees who exercise

significant latitude and independent judgment. Often heads one or more departments or a large

centralized staff function. In some instances may be responsible for a functional area (as determined by

executive management) and not have subordinate supervisors or employees. May manage employees

across multiple regions.

Working Conditions and Environment: Work is performed in an office environment with exposure to electrical office equipment Constant interaction with clients/associates required Must pay constant attention to detail-visual, mental Must be able to multi-task constantly Long, varied hours required occasionally Daily exposure to high pressure, intense concentration Occasional drives to site locations, frequent travels both domestic and international

#LI-PA1 Submission for the position: Associate Director, Medical Communications (Pharmacovigilance) - (Job Number: 175683)

Job posted: 2020-10-20

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