Principal Med Writer

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.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.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 forecastingWorking ConditionsWork 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 DemandsAbility 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.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.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 forecastingWorking ConditionsWork 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 DemandsAbility 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.Pharmaceutical Product Development, LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.