Program Mgr Med Writing

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services part of Thermo Fisher Scientific - thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.   

Unique opportunity as a dedicated Program Manager within a clinical phase medical writing group. Leverages experience as a medical writer to serve as a subject matter expert for medical writing deliverables. Works with a diverse client base with exposure to a variety of therapeutic areas, indications, and therapeutic innovations. Leads client programs with prominent visibility among internal and client teams, with a high degree of client engagement and management. Manages client relationships and identifies and resolves client management issues. Manages and ensures the quality and timely delivery of multiple program documents. Collaboratively resources projects and leads writing teams in a matrix management environment. Develops, monitors, and adapts project plans, client and program-specific processes, timelines, and budgets/forecasting for programs.

The PPD FSP Solution:

PPD's Functional Service Provider division partner with and serve as an extension of our PPD team, supporting our customer's key functions.  We cover customer needs on every level, allowing them to do more with less, with an uncompromising commitment to quality. We deploy the same top-tier talent in ALL engagement models. Exceptionally trained, rigorously supported and technologically empowered to help customers manage capacity and set programs up for success.

You will be a part of a team who is dedicated to its people and foster a supportive, collaborative culture based on trust, flexibility and work life balance. 

Essential Functions:

• Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects.
• Serves as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
• Ensures compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews, and manages performance metrics for assigned projects.
• Provides training for medical writers on scientific content of medical writing deliverables, medical writing best practices, and technical aspects of program management.
• May serve as backup medical writer.

Education and Experience:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred

• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

• Experience in managing and directing complex medical writing projects required

• Experience working in the pharmaceutical/CRO industry preferred

• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

• 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:

• Solid program management skills to include budgeting, forecasting and resource management

• Extensive knowledge of global, regional, national and other document development guidelines

• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.

• Excellent interpersonal, oral and written communication, and presentation skills

• Excellent negotiation skills

• Self-motivated and adaptable

• Excellent judgment; high degree of independence in decision making and problem solving

• Capable of mentoring and leading junior level staff

General Remote Based

PPD values the health and wellbeing 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.

• Ability 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.

What we offer

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential. 

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. 

Our 4i Values: 

Integrity – Innovation – Intensity – Involvement

If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.