Scientific Writer

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:

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. Additional tasks and responsibilities include:

⦁ 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.

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:

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. Additional tasks and responsibilities include:

⦁ 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.

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).

Knowledge, Skills and Abilities:

Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software 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

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:

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).

Knowledge, Skills and Abilities:

Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software 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

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.