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Sr Medical Writer (remote)

Pharmaceutical Product Development (PPD)

NC-Morrisville

PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

PPD’s mission is to improve health.

At PPD, you will be on the front-line of making a difference in quality of life. Your work will matter here and you will be appreciated.

What are a few details this position be involved with daily?

This is a regulatory lead writing role that requires experience on Protocol, IB and CSR documents.

Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.

Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.

Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.

May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.

Represents the department at project launch meetings, review meetings, and project team meetings.PPD’s mission is to improve health.

It starts as an idea to cure. It becomes a life saved. All in-between, it’s you!

We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside bright and energetic teams.

PPD’s mission is to improve health.

At PPD, you will be on the front-line of making a difference in quality of life. Your work will matter here and you will be appreciated.

What are a few details this position be involved with daily?

This is a regulatory lead writing role that requires experience on Protocol, IB and CSR documents.

Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.

Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

Reviews routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.

Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.

May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.

Represents the department at project launch meetings, review meetings, and project team meetings.Education:Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferredPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to5 years).Experience working in the pharmaceutical/CRO industry preferredAdditional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities:Must possess the ability to manage large projects with minimal supervisionMust possess the ability to coordinate production of deliverables and provide leadership to a project teamMust possess independence in decision making and problem solvingMust demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical WritingMust possess all requisite skills of the Medical Writer position, including excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being 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.

May require travel. (Recruiter will provide more details). Education:Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferredPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to5 years).Experience working in the pharmaceutical/CRO industry preferredAdditional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills and Abilities:Must possess the ability to manage large projects with minimal supervisionMust possess the ability to coordinate production of deliverables and provide leadership to a project teamMust possess independence in decision making and problem solvingMust demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical WritingMust possess all requisite skills of the Medical Writer position, including excellent grammatical, editorial, and proofreading skills, and the ability to interpret and present extremely complex data

PPD is an inclusive equal employment opportunity company. We value all people regardless of background, experience and abilities.

PPD values the health and well-being 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.

May require travel. (Recruiter will provide more details).

Job posted: 2020-08-15

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