Associate Scientific Writer - Vaccines

Title: Associate Scientific Writer Department: Vaccine Sciences Location: Remote based

*This is an immediate, full-time opening with great benefits!*

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!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As an Associate Scientific Writer, you will assist in the preparation and review of scientific documents.

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.  

Summarized Purpose: 

Assists in the preparation and review of scientific documents under general supervision to meet or exceed quality standards. Writes and edits basic to moderately complex analytical methods, reports and protocols for potential submission to regulatory authorities.

Essential Functions:   Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation. Compiles laboratory data into a specified report format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications. Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs. Works with senior staff to determine approach for new assignments. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. Performs other duties as assigned.

#LI-AP1 Title: Associate Scientific Writer Department: Vaccine Sciences Location: Remote based

*This is an immediate, full-time opening with great benefits!*

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!  

Envision a workplace where you have a direct impact on improving health, work alongside expert scientists, use newest technologies and collaborate with industry thought leaders and therapeutic experts. Welcome to PPD® Laboratories, where science is our passion, quality is our commitment and people are the cornerstone of our success. 

As an Associate Scientific Writer, you will assist in the preparation and review of scientific documents.

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.  

Summarized Purpose: 

Assists in the preparation and review of scientific documents under general supervision to meet or exceed quality standards. Writes and edits basic to moderately complex analytical methods, reports and protocols for potential submission to regulatory authorities.

Essential Functions:   Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation. Compiles laboratory data into a specified report format. Ensures that hardcopy and electronic reports are consistent and comply with required formats. Reviews data tables and listings and ensures that errors are corrected. Performs a quality control review of scientific documents prior to creation of the final pdf deliverable. Ensures compliance with PPD, Client, eCTD policy and procedure on publications. Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs. Works with senior staff to determine approach for new assignments. Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents. Performs other duties as assigned.

#LI-AP1

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 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities: Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts Good knowledge of Microsoft word, table and graph creation, experience with Adobe products Strong computer skills Working knowledge of industry regulations, ICH or other regulated environments Working knowledge of analytical laboratory procedures Effective written and oral communication skills Detail oriented Time management skills Good editorial and proofreading skills Good problem solving and troubleshooting abilities Ability to work well in a collaborative team environment

Working Environment: 

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, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.     

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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 2 years’) or equivalent combination of education, training, & experience.

Knowledge, Skills and Abilities: Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts Good knowledge of Microsoft word, table and graph creation, experience with Adobe products Strong computer skills Working knowledge of industry regulations, ICH or other regulated environments Working knowledge of analytical laboratory procedures Effective written and oral communication skills Detail oriented Time management skills Good editorial and proofreading skills Good problem solving and troubleshooting abilities Ability to work well in a collaborative team environment

Working Environment: 

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, including infectious agents, typically found in healthcare or laboratory environments.  Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.     

PPD Defining Principles: 

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - 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