Medical Writer - Customer Dedicated (FSP) contract opportunity

Submission for the position: Medical Writer - Customer Dedicated (FSP) contract opportunity - (Job Number: 167902)*Various Seniority Levels

*Home-Based/Remote Based Contract/Temp Opportunity*Full Time (FTE 1.0)*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

The Medical Writer will research, prepare, and coordinate scientific publications. Will also be responsible for researching, writing, and editing clinical/statistical reports and study protocols, and summarizing data from clinical studies for submission to the Food and Drug Administration (FDA).

*Various Seniority Levels

*Home-Based/Remote Based Contract/Temp Opportunity*Full Time (FTE 1.0)*6 month duration

Do you prefer flexible work options that allow you to work as a contractor, while also being immersed in the PPD Culture?

Apply today to learn more about current and upcoming contractor opportunities through our Functional Service Partnership team. Functional Service Partnership Homepage: https://www.ppd.com/our-solutions/clinical/fsp/

The Medical Writer will research, prepare, and coordinate scientific publications. Will also be responsible for researching, writing, and editing clinical/statistical reports and study protocols, and summarizing data from clinical studies for submission to the Food and Drug Administration (FDA).

Education and Experience:

BS/BA in a scientific discipline(or licensed certification) with 5 years relevant medical writing experience in a CRO or Pharma environment.

Advanced degree with 2 years relevant writing experience2 years relevant experience as a medical writer, preferably within the pharmaceutical industry

Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilitiesExperience as lead writer on protocols, CSRs, investigator brochures is required. Experience as a lead writer on IND in eCTD format and FDA meeting briefing documents in preferable.Experience working directly with clientsExperience doing QC, source data verification, and editorial reviews is a plusKnowledge, 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 solving

Must demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing

Must 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 dataWorking Conditions:Work is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Demands:Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

Education and Experience:

BS/BA in a scientific discipline(or licensed certification) with 5 years relevant medical writing experience in a CRO or Pharma environment.

Advanced degree with 2 years relevant writing experience2 years relevant experience as a medical writer, preferably within the pharmaceutical industry

Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilitiesExperience as lead writer on protocols, CSRs, investigator brochures is required. Experience as a lead writer on IND in eCTD format and FDA meeting briefing documents in preferable.Experience working directly with clientsExperience doing QC, source data verification, and editorial reviews is a plusKnowledge, 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 solving

Must demonstrate an ability to serve as a departmental resource for training, mentoring, and the development of process improvements for Medical Writing

Must 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 dataWorking Conditions:Work is performed in an office/ laboratory and/or a clinical environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office equipment. Personal protective equipment required such as protective eyewear, garments and gloves.

Physical Demands:Ability to work in an upright and /or stationary position for 6-8 hours per day.

Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Frequent mobility required. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Frequently interacts with others to obtain or relate information to diverse groups.

Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Regular and consistent attendance.

United States, US-Wisconsin, US-Michigan, US-Massachusetts, US-Ohio, US-Maryland, US-Texas, US-North Carolina, US-California, US-Pennsylvania, US-Colorado, US-New Jersey, US-NC-Morrisville, US-Virginia, US-Illinois, US-Kentucky, US-District of ColumbiaUnited States, US-Wisconsin, US-Michigan, US-Massachusetts, US-Ohio, US-Maryland, US-Texas, US-North Carolina, US-California, US-Pennsylvania, US-Colorado, US-New Jersey, US-NC-Morrisville, US-Virginia, US-Illinois, US-Kentucky, US-District of ColumbiaSubmission for the position: Medical Writer - Customer Dedicated (FSP) contract opportunity - (Job Number: 167902)