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Principal Med Writer- United States home-based!

Pharmaceutical Product Development (PPD)

NC-Morrisville-Morrisville NC 3900 Paramou

Amazing opportunity to join our global medical writing team!

Researches, authors, and coordinates development of scientific documents, communication materials and deliverables. Provides substantive advice on strategy, regulations and industry best practices. Manages medical writing projects by monitoring project budget parameters and delivering quality documents within agreed timelines and within client expectations. Trains, directs and advises internal and external medical writing professionals.

*LI-KF1

Amazing opportunity to join our global medical writing team!

Researches, authors, and coordinates development of scientific documents, communication materials and deliverables. Provides substantive advice on strategy, regulations and industry best practices. Manages medical writing projects by monitoring project budget parameters and delivering quality documents within agreed timelines and within client expectations. Trains, directs and advises internal and external medical writing professionals.

*LI-KF1

Education and Experience:Bachelor's degree in a science-related fieldPrior experience within medical writingPrior experience in managing and directing complex medical writing projectsExperience within a broad range of medical writing projectsAdditional qualifications in medical writing (AMWA, RAC, etc) is advantageousBroad regulatory affairs experience is an advantageAdvanced degree (PharmD, PhD, Masters) is preferredSuitable, relevant experience working in the pharmaceutical/CRO industry is preferredKnowledge, Skills and Abilities:Excellent interpersonal skills including problem solvingAdvanced word processing, template and document management skillsGood knowledge of global / regional Medical Writing / Regulatory Affairs for clinical trials, marketing authorization and late phase proceduresExcellent understanding of computers and their applicationsEffective oral and written communication skillsAttention to detail and quality of documentGood and effective organizational and planning skillsNegotiation skillsSelf-motivated and adaptableAble to multitaskAble to plan own work well in advanceAble to work on own initiativeProven ability to work effectively in a teamAble to teach/mentor team membersAble to motivate and integrate teamsMental skills required in areas of: Numeracy, Language, Analytical, Investigative, verbal and written communication, Attention to detail, Customer contact, Multiple project handling, Reading and interpretation of dataExcellent knowledge of Global Regulatory Affairs ProceduresGood knowledge of global / regional / national document development requirementsExcellent knowledge of relevant ICH and other global regulatory and document development guidelinesGood in-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.Able to manage and plan multiple complex projectsAble to direct the work of othersExcellent judgment and decision-making skillsAble to act as liaison with other Divisions where necessary (i.e., Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, Late Stage, etc)Knowledge of budgeting and forecastingPPD 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 and Experience:Bachelor's degree in a science-related fieldPrior experience within medical writingPrior experience in managing and directing complex medical writing projectsExperience within a broad range of medical writing projectsAdditional qualifications in medical writing (AMWA, RAC, etc) is advantageousBroad regulatory affairs experience is an advantageAdvanced degree (PharmD, PhD, Masters) is preferredSuitable, relevant experience working in the pharmaceutical/CRO industry is preferredKnowledge, Skills and Abilities:Excellent interpersonal skills including problem solvingAdvanced word processing, template and document management skillsGood knowledge of global / regional Medical Writing / Regulatory Affairs for clinical trials, marketing authorization and late phase proceduresExcellent understanding of computers and their applicationsEffective oral and written communication skillsAttention to detail and quality of documentGood and effective organizational and planning skillsNegotiation skillsSelf-motivated and adaptableAble to multitaskAble to plan own work well in advanceAble to work on own initiativeProven ability to work effectively in a teamAble to teach/mentor team membersAble to motivate and integrate teamsMental skills required in areas of: Numeracy, Language, Analytical, Investigative, verbal and written communication, Attention to detail, Customer contact, Multiple project handling, Reading and interpretation of dataExcellent knowledge of Global Regulatory Affairs ProceduresGood knowledge of global / regional / national document development requirementsExcellent knowledge of relevant ICH and other global regulatory and document development guidelinesGood in-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.Able to manage and plan multiple complex projectsAble to direct the work of othersExcellent judgment and decision-making skillsAble to act as liaison with other Divisions where necessary (i.e., Project Management, Clinical Supplies, QA, Clinical Management, Data Management, Biostatistics, Late Stage, etc)Knowledge of budgeting and forecastingPPD 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: 2020-06-19

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