Associate Manager Scientific Writing

Pharmaceutical Product Development (PPD)

WI-Middleton-Middleton WI Deming Way


PPD is a leading global contract research organization - currently operating in 46 countries! At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Our organization works with a diverse group of pharmaceutical companies to help accelerate timelines to develop and deliver life changing medicine and therapies. As the largest GMP laboratory in North America, our lab in Middleton, WI offers the most comprehensive set of laboratory services available in the industry.

Role Description:

Prepares and reviews scientific documents to meet or exceed quality expectations. Interacts with the Laboratory to determine format and design of complex scientific documents for potential submission to regulatory authorities. Uses notebook entries and data to develop report text and ensures that hardcopy and electronic reports comply with required formats. Serves as a departmental resource for training, mentoring, and the development of process improvements. Supervises daily work activities of the technical writing staff to ensure efficient and effective lab support operations. Provides short and long term resource planning in order to assign projects to appropriate and available staff. Evaluates timeliness and quality of deliverables and provide updates to senior management. Compiles raw data and statistical summaries from the laboratory database into a client specified format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Edits and performs quality control review of reports prepared by Scientific Writers and/or other writers within the organization. Reviews data tables and listings to ensure accuracy. Organizes processes for writing analytical reports. Interacts with the sponsor to determine format, design, and direction of analytical reports. Represents the laboratory on project teams and updates team members on the status of study reports. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. Trains staff on writing skills and procedures for preparing documents. Assesses the competency of staff in the unit and issues formal evaluations.

PPD is a leading global contract research organization - currently operating in 46 countries! At PPD we are passionate, deliberate, and driven by our purpose - to improve health. Our organization works with a diverse group of pharmaceutical companies to help accelerate timelines to develop and deliver life changing medicine and therapies. As the largest GMP laboratory in North America, our lab in Middleton, WI offers the most comprehensive set of laboratory services available in the industry.

Role Description:

Prepares and reviews scientific documents to meet or exceed quality expectations. Interacts with the Laboratory to determine format and design of complex scientific documents for potential submission to regulatory authorities. Uses notebook entries and data to develop report text and ensures that hardcopy and electronic reports comply with required formats. Serves as a departmental resource for training, mentoring, and the development of process improvements. Supervises daily work activities of the technical writing staff to ensure efficient and effective lab support operations. Provides short and long term resource planning in order to assign projects to appropriate and available staff. Evaluates timeliness and quality of deliverables and provide updates to senior management. Compiles raw data and statistical summaries from the laboratory database into a client specified format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Edits and performs quality control review of reports prepared by Scientific Writers and/or other writers within the organization. Reviews data tables and listings to ensure accuracy. Organizes processes for writing analytical reports. Interacts with the sponsor to determine format, design, and direction of analytical reports. Represents the laboratory on project teams and updates team members on the status of study reports. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. Trains staff on writing skills and procedures for preparing documents. Assesses the competency of staff in the unit and issues formal evaluations.

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years) or equivalent and relevant combination of education, training, & experience.

1 year of leadership responsibility

Knowledge, Skills and Abilities:

Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts

Working knowledge of complex analytical laboratory procedures

Strong time management and project management skills

Excellent written and oral communication skills

Proficient with Microsoft Office

Strong attention to detail

Strong editorial/proofreading skills

Proven problem solving and troubleshooting abilities

Demonstrated leadership abilities

Ability to motivate and train staff individually and in a team environment

Work Environment Requirements

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 and/or standing for typical working hours

· Able to lift and move objects up to 25 pounds

· Able to work in non-traditional work environments

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

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

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

What To Expect Next

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves. Join PPD in our relentless pursuit of excellence! If you feel your skills are a fit for this position - apply now!

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.

Education and Experience:

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0 to 5 years) or equivalent and relevant combination of education, training, & experience.

1 year of leadership responsibility

Knowledge, Skills and Abilities:

Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts

Working knowledge of complex analytical laboratory procedures

Strong time management and project management skills

Excellent written and oral communication skills

Proficient with Microsoft Office

Strong attention to detail

Strong editorial/proofreading skills

Proven problem solving and troubleshooting abilities

Demonstrated leadership abilities

Ability to motivate and train staff individually and in a team environment

Work Environment Requirements

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 and/or standing for typical working hours

· Able to lift and move objects up to 25 pounds

· Able to work in non-traditional work environments

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

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

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

What To Expect Next

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. It's not just talk, our award-winning training programs speak for themselves. Join PPD in our relentless pursuit of excellence! If you feel your skills are a fit for this position - apply now!

We look forward to receiving your application. A member of our talent acquisition team will review your qualifications and if interested, you will be contacted for an interview.


2020-06-24 00:00:00


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