Scientist Principal Resume Sample

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Work Experience


Data Scientist Principal Director
06/2016 - PRESENT
Chicago, IL
  • Collaborate with project teams to respond to heath authority questions and requests
  • Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner
  • Prepare and manage project plans and timelines
  • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed
  • Understand and support the nature of our business and our company’s commitment to quality and responsiveness
  • Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance
  • Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail
Principal Clinical Data Scientist
12/2009 - 01/2016
New York, NY
  • Technology Leadership
  • Effectively interfaces with the Translational Medicine group to obtain appropriate resources to deliver on biomarker goals
  • Implementation of process improvement plans to enhance organizational efficiency and continuous improvement
  • Master or PhD, Microbiology, Biochemistry, Toxicology or related field
  • Experience within corporate or regulatory environment
  • Formal technical reporting
  • Human health assessment knowledge
  • Food and Water contact regulations
  • Familiarity with global materials regulatory, includes but not limit to, Prop 65, RoHS, REACh, Packaging, Batteries and other material
Assoc Principal Scientist
11/2003 - 07/2009
Houston, TX
  • Good teaming and communication skills
  • Understanding of legal compliance and opinions
  • Self-directed work ethic, strong interpersonal and influencing skills and serious ability to multi­task
  • Interpret data, analyze published literature, define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions
  • Manage and direct client project teams, including identifying, directing, and delegating tasks necessary for successful document completion
  • Willingness to mentor and help other medical writers in the writing, editing, and compilation of documents
  • Organize/prioritize work with limited guidance and manage projects in a timely and effective manner; work on multiple projects simultaneously, and reorganize and reschedule work as needed in order to meet client deadlines
  • Interpret, present and report research findings at internal meetings and external scientific conferences
  • Strong Medical Writing/Editing Experience

Education


University of Minnesota, Morris
1998 - 2003
Bachelor's Degree in Statistics

Professional Skills


  • Strong laboratory and experimental skills, data analysis and verbal communication skills, ability to multitask, collaborate and prioritize
  • Strong organization and prioritization skills with a demonstrated ability to work in a fast-paced, rapidly changing environment is required
  • Highly effective interpersonal skills with excellent written and verbal communications in line with target audience, promoting effective decision-making
  • Strong problem-solving skills exhibited by the ability to approach complex, ambiguous business issues with creative ideas and solution
  • Excellent group interaction and negotiating skills
  • Strong organizational and technical leadership skills and good understanding of analytical techniques
  • Effective leadership skills and proven ability to foster team productivity in a cross-functional environment is required

How to write Scientist Principal Resume

Scientist Principal role is responsible for leadership, interpersonal, analytical, procurement, analysis, design, research, modeling, influencing, programming.
To write great resume for scientist principal job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Scientist Principal Resume

The section contact information is important in your scientist principal resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Scientist Principal Resume

The section work experience is an essential part of your scientist principal resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous scientist principal responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist principal position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Scientist Principal resume experience can include:

  • Demonstrates leadership and experience in the area of pre-formulation, formulation and process development of immediate and modified solid dosage forms
  • Overseeing the tactical execution of the operational strategy by the partner CRO; effectively leads the study through oversight of the CRO
  • Computational and programming skills for working with “big data”
  • Several years experience in development of solid dosage forms
  • Develops and manages the execution of the validation and integration plans, including the validation plan, dataset definition and external data sources
  • Well organized and methodical, yet flexible in adjusting priorities, and able to take risks to accomplish goals

Education on a Scientist Principal Resume

Make sure to make education a priority on your scientist principal resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist principal experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Scientist Principal Resume

When listing skills on your scientist principal resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical scientist principal skills:

  • Hands-on modeling skills and strong analytic programming skills using R, SAS, Matlab, or Python
  • Strong organizational, planning and communication skills are essential
  • Willingness and ability to effectively cooperate and partner with external providers and others within BMS
  • Strong management skills and personnel development aptitude
  • Demonstrates exceptional conflict management and negotiation skills
  • Negotiating and Influencing skills, identifying win/win solutions

List of Typical Experience For a Scientist Principal Resume

1

Experience For Data Scientist Principal Director Resume

  • Strong experience designing and managing research projects and creating nutrition science based communications
  • Demonstrated experience working with complex, large-scale data sets in an advanced data mining analytic role
  • Evidence of forging strong relationships with internal stakeholders, i.e. sales, product managers, marketing, regulatory, applications, etc
  • Software modeling/coding experience with tools such as Python, MATLAB
  • Participate in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics
  • Experience in engaging with NGO and health care professional organizations on nutrition science & policy issues
  • Experience with drug product manufacturing processes development for therapeutic proteins, process scale-up and optimization
2

Experience For Principal Clinical Data Scientist Resume

  • Support the Clinical Program Director in developing clinical evidence generation plans
  • Experience in the development and integration of analytic tools, models, and simulations
  • Experience of applied microbiology in the food industry and laboratory/dept. management
  • Representing process requirements from design through to installation, commissioning, qualification and transfer to operations,
  • Managing both small and large capital projects,
  • Capable of leading, planning, and executing the development and testing of sensors, including debugging hardware and software desired
  • Create a value chain to help address the challenges of acquiring data, evaluating its value, distilling & analyzing
  • Completes all time reporting, training, metrics database, and project tracking updates as required
3

Experience For Assoc Principal Scientist Resume

  • Provides technical expertise and support when implementing model results in Waste Management's ongoing business processes
  • Provides input to protocol and Study Data Quality Plan during the planning phase
  • Develop business methods and procedures, including accounting systems, file systems, office systems, logistics systems, and production schedules
  • Literature research on cutting edge study in related fields to bring on new ideas and approaches to our business problems
  • Scientific/research background (i.e., has understanding of research design, methodology, and statistics)
  • Principal Research Scientist applies expert knowledge of tumor biology in areas such as immune oncology, oncogenic signaling, metabolism, epigenetics and/or DNA damage to enable target discovery, validation and drug development
  • Provide training on processes, scientific topic as needed
  • Responsible for the execution and standardization of COA-related activities including
4

Experience For Principal R&D Scientist Resume

  • Capital planning and forecast,
  • Point of contact for more complex data management and data quality considerations including regular contact with monitors
  • Inputs into the data capture tools for a clinical study, including the eCRF and ePRO
  • Applies internal standards, regulatory, and publishing guidelines
  • Actively participates or leads process working groups
  • Able to lead compound/submission/indication/disease DAS writing teams with supervision
  • Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed
  • Generates high quality laboratory-based investigative data to support portfolio progression and/or mechanistic understanding of toxicity findings
5

Experience For Principal Medical Writing Scientist Resume

  • Develop and provide nutrition education and training for internal EMEA audiences
  • Pertinent SOP’s related to pharmaceutical laboratory testing, analyses and documentation
  • Deep understanding of the role of translational research/medicine and clinical biomarkers in drug development
  • MS in (bio) statistics, applied statistics, applied mathematics, machine learning, or similar quantitative fields of study
  • Ph.D. in (bio) statistics, applied statistics, applied mathematics, machine learning, or similar quantitative fields of study
  • In applying model based methods in pre-clinical and clinical drug development.
  • Preclinical and clinical study design, execution, and understanding of statistical analysis
  • Meet with other scientists and analysts across Field Marketing organization to identify business objectives
6

Experience For Data Scientist Principal Resume

  • Follow-up with stakeholders by providing a detailed research project definition and expectation of the timeline
  • An understanding of the biology of disease
  • Translate complex genetic or medical research questions into statistical questions and analysis strategies
  • Detect problems in data or analytic results and find appropriate remedies
  • Manage projects with multiple collaborators
  • Write clearly and prepare results for publication
  • Prepares documentation for ANDA submissions
  • Develops and executes formulation strategies related to product development, e.g. project planning and timelines, experimental design, data evaluation, formulation of relevant and scientifically based conclusions, coordinates studies with other technical groups (Analytical Sciences, Legal and Regulatory & Pharma Tech)
  • Writes protocols and batch records to carry out process development and evaluation work, scale up and pivotal batch manufacturing for Abbreviated New Drug Applications (ANDA's) submission to regulatory agency
7

Experience For Director, Principal Scientist Resume

  • Plans appropriate analytical testing and stability studies on pivotal batches
  • Performs appropriate documentation and prepares pharmaceutical product development report (PDR), Quality overall Summary (QOS) and other necessary documents to support regulatory filing of ANDA's
  • Carries out lead responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws
  • Creates, manages, or participates in clinical study or clinical evaluation timelines, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
  • Participates in the development of clinical strategy and trial design by conducting meetings with the appropriate departments and individuals to obtain feedback/direction
  • Work with the development teams to design and analyze DOE’s during feasibility and early development phases
8

Experience For Principal Scientist, Biostatistics Resume

  • Work with the CRO’s and pharma partners to develop the Statistical Analysis Plans for all clinical trials
  • Involved in research activities for innovative statistical methods and applications in clinical trial development
  • Establish in collaboration with head of BBU MA and Affiliate medical Leads the medical strategy,
  • Review and approve IITs/ Biogen local studies to ensure medical and scientific quality and alignment with BBU strategy
  • With support from Global Medical research, develop processes for BBU clinical research projects development (from pre-concept to global LCMF approval). Ensure all processes are implemented and executed by medical affiliates
  • Ensure and strengthens processes and relationship with BBU partner SamsungBioepis
9

Experience For Research Scientist Principal Resume

  • Provide support to Affiliate Medical Leads to ensure adequate and efficient implementation of BBU medical strategy
  • Manufacturing equipment includes a variety of lab equipment such as fermenters, HPLC’s, UPLC’s, and Spectrophotometers. Manufacturing equipment also includes label printing, and filling and packaging lines
  • Provide technical guidance and direction to ensure the group meets and achieves project milestones
  • Contribute to and help define and implement the pharmacology research strategy aligned with MSD Research Laboratories (MRL)’s drug discovery approaches and organizational objectives and serve as a resource for technical, pharmacological, biological and drug discovery expertise
  • Optimize technology to support scientific/business processes, seeks opportunities and provides recommendations to enhance technology and support systems and adopt a continuous improvement approach to all lab-based activities to improve safety, quality, speed, efficiency and costs
10

Experience For Principal Scientist, Medical Writing Resume

  • Ensure all activities comply with appropriate health and safety legislation, company codes of practice and local rules. Promote the culture of safety and compliance among colleagues
  • Combine traditional Machine Learning techniques and the latest Deep Learning methodologies to advance the company’s Search Science modeling capabilities
  • Stay up to date on the latest industry trends in Big Data, Machine Learning Recommendation and Personalization, Deep Learning, and adopt them as
  • Develop global COA endpoint strategic plans in collaboration with Early Development Teams (EDTs), Value Evidence Sub-teams (VESTs) and Clinical Sub-teams (CST) to assure alignment with product franchise goals
  • Coordinate and lead the development, validation, analysis, interpretation and utilization of instruments aimed at measuring COAs in the context of clinical trials and/or observational studies
  • Provide guidance, create and/or review dossiers to be submitted to Regulatory Authorities and/or HTA agencies to assure consistency and alignment with COA strategies and represent Merck during these interactions
  • Provide guidance on sections of protocols, CRFs, SAPs and reports related to COAs

List of Typical Skills For a Scientist Principal Resume

1

Skills For Data Scientist Principal Director Resume

  • Strong scientific, medical writing skills including the ability to interpret and organize scientific data is also required
  • Experience effectively managing internal and contract research laboratories in clinical studies
  • Advanced practical knowledge and demonstrated experience leading and developing statistical models and methods
  • Demonstrated experience publishing peer-reviewed scientific literature, software documentation, or Navy guides and/or handbooks
  • Demonstrated experience in meeting Navy METOC operational requirements
  • Demonstrates the ability to work independently and/or in a team environment delivering strong results
2

Skills For Principal Clinical Data Scientist Resume

  • Highly developed project management and organizational skills
  • Experienced scientist with 7+ years’ experience in the drug development process
  • Demonstrated experience in the appropriate application of various scientific technologies into translational research strategies
  • Relationship management skills – ability to influence and work with other functions e.g. regulatory, quality, procurement across geographies
  • Function effectively both independently and in a team environment
  • Building effective teams and motivating others
  • Programming experience, preferably in C or C#
3

Skills For Assoc Principal Scientist Resume

  • Three-to-five years of experience developing, testing, and transitioning Navy operational NWP software systems
  • Three-to-five years of experience developing, testing, and transitioning Navy operational DA software systems
  • Experience solving analytical problems using quantitative approaches/Machine Learning
  • Hands on experience conducting laser or optical system experiments, tests, collecting and analyzing data
  • Industry experience solving analytical problems using quantitative approaches/Machine Learning
  • Extensive experience writing and editing clinical regulatory documents
  • Experience in developing and driving a strategy
  • Experience in using Microsoft Word or other applicable word processing software is required
  • Highly organised with ability to prioritise work and remain focused on objectives in rapidly changing circumstances maintaining the highest quality
4

Skills For Principal R&D Scientist Resume

  • Good understanding of the regulatory guidelines governing cGMP manufacture (and specific Merck guidelines) is critical
  • Demonstrated knowledge of large relational databases, and advanced SQL programming
  • Provides demonstrated work and familiarity with data mining and visualization tools
  • Experience in taking laser concepts through all development phases to qualification
  • Relevant regulatory medical writing experience is required
  • Proven learning agility with the ability to quickly assimilate and apply knowledge is required
5

Skills For Principal Medical Writing Scientist Resume

  • Good understanding of worldwide regulatory requirements and clinical trial expertise from phase I to II
  • Previous automation experience supporting production of biologics or GMP operations
  • Previous experience in processing of biologics, GMP operations, safety / biosafety, environment is required
  • Machine learning, business intelligence and quantitative analysis experience
  • BS/MS with at least 5 yrs. of “hands-on” experience in the development, execution and interpretation of in vivo studies
  • Experience with laboratory optical systems set up and measurements
  • Knowledge and research experience with LIDAR systems
  • Experience in quality, R&D, or operations
6

Skills For Data Scientist Principal Resume

  • Pharma, CRO and/or ARO experience
  • Demonstrates the discipline of project management to plan, organize and manage activities to deliver specific study goals and objectives to measurable targets
  • Career experience in optics is required
  • Experience with Fiber Lasers is required
  • Demonstrate the ability to learn, be proactive and motivated, and consistently focus on details and execution
  • Experience in mechanical system, process system, and process control design
  • Quality Development systems and cGMP experience
  • Purification, bioreactor operation, HVAC, and/or Utility System design/operations experience
7

Skills For Director, Principal Scientist Resume

  • Strong algorithmic background
  • PLC and/or DeltaV experience
  • Strong technical background in several bio-process unit operations is required
  • PhD and six years of experience in statistical genetics or closely related area
  • Providing/leading ongoing automation system and IT support and projects in the Biologics Pilot Plant Automation and Process Engineering Group
  • Partnering with GCO Vendor Management to escalate issues, sharing best practices and leveraging the Vendor Operations Relationship Manager for issue resolution
  • Driving upgrade and ongoing maintenance projects and managing the GMP automation documentation on all systems in the facility
8

Skills For Principal Scientist, Biostatistics Resume

  • Supporting the Regional MA lead or Regional/ Country Medical Affairs Principal Scientist in delivering the annual goals and objectives activities
  • Developing and maintaining facility documentation
  • Leading the troubleshooting on various automation system technologies
  • Operating in a task force mode where additional resources are necessary and cross training in many areas and technologies
  • Leading in the design, scope, implementation, and maintenance of pilot plant projects
  • Supporting all automation needs across the facility
  • Understanding of modulation schemes for digital communications
  • Understanding of disease area
  • Understanding of laboratory data
9

Skills For Research Scientist Principal Resume

  • Mediate conflicts by negotiating, compromising, persuading, and facilitating the open exchange of ideas and opinions
  • Willingness and ability to work hands-on in the lab building, troubleshooting, and optimizing breadboard systems and prototypes
  • Optical engineering and analyses capabilities such as optical design, ray tracing, stray light analyses, beam propagation etc are desired
  • Windows XP networking/administrator, Oracle, Visual Basic Programming, POMS, MES, Active Directory
  • Help to create and define compelling vision, drive change, influence decision making
10

Skills For Principal Scientist, Medical Writing Resume

  • Ensure proper medical budget tracking, regular clinical research activities reporting to senior management
  • Ensure Study tracking (from concept to execution, including budget)
  • Advanced understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology
  • Manage challenging, high-value projects
  • Develop a strategy for as a service pricing that aligns to Accenture Operations’ overall market strategy
  • Provide technical support to the region’s key players (sales, product management, marketing, regulatory)
  • Keep abreast of emerging science and policy issues in the nutrition and health environment and identify nutrition-related business opportunities in the region
  • High understanding of end-to-end data flow and business logic

List of Typical Responsibilities For a Scientist Principal Resume

1

Responsibilities For Data Scientist Principal Director Resume

  • Excellent interdepartmental communication, influence and documentation skills are required
  • Demonstrate the effectiveness and impact of the analytical tools developed to support efforts in demonstrating the value of our medical technologies
  • Effectively communicates experimental findings in both oral and written formats
  • Communication skill and proficient project management experience
  • Academic experience in/or clinical design experience
  • Demonstrate strong interest in statistical research activities and in application of novel methods to non-clinical or clinical studies
  • Demonstrated experience with member engagement analytics
  • Strong foundation in the food / food ingredients industry with experience in science communications and knowledge of the regulatory environment in Europe
2

Responsibilities For Principal Clinical Data Scientist Resume

  • Solid understanding of the engineering guidelines and associated cGMPs, safety/biosafety, and environmental expectations is required
  • Demonstrates independent and creative scientific thinking, ability in solving complex problems, and resilience to setbacks and changes
  • Experience in communications systems engineering and analysis (e.g. link budgets and simulation modeling)
  • Demonstrated ability to deliver results against challenging schedules
  • Prosecute novel therapeutic proteins to demonstrate proof-of-principle using in-house capabilities as well as external resources (CROs)
  • Strong technical competence in organic chemistry, bio-conjunction, analytical methods, synthesis and purification
  • Experience with statistics, Statistical Process Control and DOE techniques is highly desired
  • Work in a fast pace environment, manage priorities, and flexible to work on multiple projects
3

Responsibilities For Assoc Principal Scientist Resume

  • Knowledge of cGMPs, regulatory guidelines and good laboratory practice are essential
  • Prioritize and manage multiple complex projects
  • PhD in biology, microbiology, pharmacology or life-sciences-related field with 3-7 years of industry experience
  • Solid knowledge and application of regulatory guidance documents such as ICH requirements is required
  • Assay development and validation (e.g., PCR, immunoassays, immunohistochemistry)
4

Responsibilities For Principal R&D Scientist Resume

  • Demonstrates a customer service mindset
  • Project management or project coordinator experience
  • Understanding of end-to-end communication system implementations
  • Act as a scientific expert/consultant to the product development organization during all phases of product development leading to production
  • Provide project and technical leadership for programs focusing on leading edge laser technology research and development in high power fiber lasers
  • A broad understanding of the technologies and methodologies used for advanced analytics and modern data engineering
  • Organize the collection of existing information on COAs used within CORE to facilitate selection and/or development of measures for new clinical trials
5

Responsibilities For Principal Medical Writing Scientist Resume

  • Provide training on COA-related topics to new CORE members and to other Merck departments, as needed
  • Initiate, direct, and execute development activities with an emphasis on developing next generation technology, trade secrets, and intellectual property
  • Provide leadership on teams responsible for defining the direction and regulatory strategy for a clinical development program
  • High level understanding of multiple communications disciplines such as RF, optical, and wireless terrestrial communications
  • Participate in advancing Alkermes pipeline and capabilities in protein therapeutics
  • Work closely with the clinical team and VEST to interpret results from COA endpoints
  • Responsible for maintaining awareness of scientific, regulatory, and market access developments within his/her areas of expertise across Merck functional areas, both in terms of new methodology and new activities to establish communication with key outcomes research opinion leaders
6

Responsibilities For Data Scientist Principal Resume

  • Support or produce scientific communications (abstracts, poster presentations, podium presentations, manuscripts, etc.) and external communications (e.g., value evidence dossiers)
  • Keep up-to-date with methodologies and guidelines (including those from Regulatory Authorities) and communicate findings to CORE groups as needed
  • Expertise in modified release formulations
  • Expertise in bioavailability enhancement (e.g. hot melt extrusion)
  • Knowledge of relevant guidelines (e.g. ICH Q8, 9, 10)
  • Develops advanced statistical models and methodologies to predict, quantify or forecast various operational and performance metrics
  • Performs high level data analysis; develops complex algorithms and computational solutions as necessary to support the business units of the organization
  • Observes current systems/processes and interacts with the appropriate personnel. Utilizing a variety of sources collects and analyzes information to support the modeling and analysis
  • Collaborates with and as part of leadership to identify, define, and solve a variety of problems and support various corporate initiatives. Present and communicates information to all levels of the organization (including technical and non-technical audiences, Senior Leadership and Executive Leadership)
7

Responsibilities For Director, Principal Scientist Resume

  • Leads in developing business methods and procedures (including accounting systems, file systems, office systems, logistics systems, and production schedules)
  • Capital projects in support of biological clinical manufacturing in the pilot plant
  • Conducting safety reviews & HAZOPs, developing SOPs and providing leadership for a wide range BPP GMP, environmental, and safety/biosafety initiatives associated to capital efforts
  • Manage, architect and analyze big data in order to build data driven insights and high impact data models
  • Examine data from multiple sources and share insights which provide competitive advantage
  • Facilitates communication between Sales and Marketing, R&D, Regulatory Affairs, Training, Senior Management and investigational sites by conducting team meetings, drafting and sending routine correspondence (e.g., newsletters) and/or by presenting regular updates to senior staff
  • Manages clinical study timelines, budget by utilizing the appropriate project management tools, selecting providers, managing vendor contracts, and ensuring expenditures are within budgetary guidelines
8

Responsibilities For Principal Scientist, Biostatistics Resume

  • Writes study protocols, protocol amendments, informed consents, and scientific papers for publication by evaluating scientific literature and publications, analyzing scientific data and staying abreast of current clinical practice
  • Provides accurate progress reports on clinical projects by writing assigned clinical portions of reports for submission to regulatory agencies, Institutional Review Boards, Medical Ethics Committees, etc
  • Propose technology concepts that can be built into existing products or completely new technologies that are considered disruptive in nature
  • Evaluate competitive products and new technologies from research institutions aimed to enhance future products
  • Prepare complex clinical regulatory documents, including clinical study protocols, clinical study reports, and investigator’s brochures and sections of regulatory submissions
  • Serve as the lead Medical Writing Scientist for complex or pivotal clinical studies
9

Responsibilities For Research Scientist Principal Resume

  • Manage a broad range of Medical Writing activities for development programs with multiple clinical studies
  • Participate in developing key messages for highly complex clinical regulatory documents
  • Provide strategic and scientific contributions to regulatory documentation in support of the clinical development pipeline
  • Serve as core member of submission teams for marketing applications, contribute to key message development and submission strategy, prepare clinical summaries and clinical overview
  • Ensure information from team meetings and key messages are incorporated appropriately across documents
  • Provide expert review of documents
10

Responsibilities For Principal Scientist, Medical Writing Resume

  • Proactively identify process and template improvements
  • Provide expert-level input to cross-functional teams that work on standard operating procedures, process improvements, and integration of new tools and technologies
  • Takes lead as scientific project manager, writing/editing scientific content of deliverables and managing their timelines and the contribution of cross functional input
  • Writes Clinical Evaluation Plans and Clinical Evaluation Reports and other clinical deliverables
  • Creates, manages, or participates in timelines of deliverables, and budgets by utilizing the appropriate project management tools, selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
  • Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature, and staying abreast of current clinical practice
  • Participates in and supports audits
  • Global study level contribution as DQL or in close collaboration with Data Quality Leader and other members of the study team

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