United Therapeutics

Date:

August 31, 2010

Title:

Accounting Intern

Job Type:

Part-Time Position

Job Category:

Finance Accounting

Location:

Silver Spring, MD

Experience Required:

None

Education Level:

Studying to obtain Bachelor of Science Degree in Accounting or Equivalent

Role Purpose/Position Overview

Work with the general ledger team to record cash transactions within the SAP system along with recording expense reports in SAP.   

Key Accountabilities/Responsibilities

Duties will include:
•Recording recurring journal entries within SAP.
•Recording out going wire payments within the SAP system.
•Recording checks received within SAP.
•Working with expense report file to upload data into SAP system.
•Working with the general ledger team to ensure overall corporate closing deadlines are achieved.
•All other duties as assigned.

Requirements

Requirements:
•Excellent communication and interpersonal skills.
•Team player and ability to interact with individuals from multiple disciplines.
•Ability to maintain confidentiality.
•Ability to work independently with minimal supervision as well as within a group/ team.

Education:
•Studying to obtain Bachelor of Science Degree in Accounting or Equivalent.
•Successfully completed at least intermediate accounting classes.

Computer Skills:
•Microsoft Office Suite.

Qualified candidates please click here to apply!

EOE

Date:

February 19, 2010

Title:

Corporate Real Estate Coordinator

Job Type:

Full-Time Position

Job Category:

Real Estate/Facilities

Location:

Silver Spring, MD

Experience Required:

1-2 yrs relevant experience

Education Level:

BS/BA degree required

Role Purpose/Position Overview

We are looking for a Corporate Real Estate Coordinator to assist the Real Estate/Facilities department in managing global Construction, Facilities and Real Estate matters.

Key Accountabilities/Responsibilities

• Provide assistance to Corp Real Estate staff requiring additional administrative support (i.e...prepare confidentiality agreements, send faxes, copying and scanning, preparing files, filing, mailings, etc.)
• Manage contract approval process
• Data entry required
• Additional duties as assigned by your manager to achieve company goals
• Coordinate Business meetings and related travel
• Prepare and submit expense reports
• Attend and report on construction meetings; maintain minutes for specialty meetings as requested
• Execute special research projects and data analysis tasks
• Analyze problems, determines approach, compiles and analyzes data and prepares reports and recommendations
• Track project progress and budgets
• Compose all types of correspondence (written/oral communication) with contractors & various county, state and federal agencies
• Develop spreadsheets and process data (i.e. lease abstracts, lease compliance, real estate tax analysis)
• Attend community association meetings, planning meetings and hearings
• Solicit, review and comment on vendor contracts for services
• Manage project files, contracts & correspondence
• Coordinate project schedules and contact sheets
• Liaison with key consultants in relation to planning, engineering, and construction staff
• Schedule appointments and meetings

Requirements

• Good understanding of business office practices
• High energy level
• Detail oriented
• Excellent communication skills (both written and oral)
• Ability to think on your feet
• Interest in all aspects of property development
• Self starter with the ability to multitask
• Upbeat and positive personality
• Good telephone manner
• Strong work ethic
• Bottom line oriented
• Team player
• Superior organizational skills a must

Qualified candidates please click here to apply!

EOE

Date:

March 25, 2009

Title:

Project Leader, Commercial Glycobiology Products

Job Type:

Full-Time Position

Job Category:

Corporate Development

Location:

Silver Spring, MD

Experience Required:

10 + yrs

Education Level:

PhD or MD preferred

Role Purpose/Position Overview

The Project Leader, Commercial Glycobiology Product is responsible for creating and leading a team responsible for translating successful in vitro results of liposomally-encapsulated glycobiology compound against HCV into commercial products.

2010-2012 in Silver Spring, MD;  2013-Thereafter in Oxford, UK

Key Accountabilities/Responsibilities

• Building an entire clinical development team from scratch using a combination of employees and outside contractors.  
• Reports directly to the CEO

Requirements

• Successfully obtained regulatory approval of an anti-viral, preferably HBV or HCV.  Successfully helped develop a liposomally-encapsulated product.

Qualified candidates please click here to apply!

EOE

Date:

September 02, 2010

Title:

Sr. HR Generalist

Job Type:

Full-Time Position

Job Category:

HR

Location:

Silver Spring, MD

Experience Required:

5-7 years exempt level HR professional experience

Education Level:

Bachelor’s Degree required

Role Purpose/Position Overview

The Sr. HR Generalist will provide a full range of HR support to the rapidly growing organization.

Key Accountabilities/Responsibilities

Key accountabilities:

• Ensure consistent implementation of HR programs and company-wide policies, procedures and guidelines;
• Responsible for the company’s recruiting activities and manage the talent pipeline in conjunction with the team;
• Oversee the administration, implementation and communication of company’s benefits program;
• Process new hire paperwork and benefits;
• Manage employee relations issues;
• Assist with preparation of annual performance reviews;
• Assist with planning local employee events;
• Responsible for projected HR budget submission on an annual basis.

Requirements

The successful candidate must possess the following qualifications:

• Must be an excellent communicator; with an emphasis on tactfulness and professionalism
• Self-motivated
• Strong ability to multi-task in a fast-paced environment
• Produce a detail-oriented work product
• Utilize strong organizational skills
• Adaptable
• Proficient with Microsoft Office products suite
• Familiarity with ADP preferred

Qualified candidates please click here to apply!

EOE

Date:

August 04, 2010

Title:

Associate Director, MSL Program

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Research Triangle Park, NC

Experience Required:

8+ years working in the biotech / pharmaceutical industry (or appropriate clinical setting)

Education Level:

Advanced scientific or clinical degree (Pharm D., Ph.D., NP, MD) required

Role Purpose/Position Overview

Serve as the primary manager, mentor, and trainer for US Medical Science Liaisons.  Serve as a senior level field-based point of contact for current and future clinical investigators, speakers, and other health care providers on a range of clinical and scientific issues.  Provide strategic leadership on Medical Affairs contributions across the UT organization, to ensure strategic alignment on key clinical and commercial projects.

Key Accountabilities/Responsibilities

• Manage the US MSL team, including hiring, performance, training, mentoring, strategic direction (in conjunction with senior Medical Affairs leadership), compliance, and other administrative issues
• Work directly with the leadership of Sales, Marketing, and Clinical to ensure broad strategic alignment with respect to key initiatives
• Assume responsibility for US MSL T&E, training, and professional development budget, as assigned by Director/Sr. Director of Medical Affairs
• Provide Medical Affairs leadership to assist commercial team with certain aspects of promotional speakers program, including speaker training, quality assurance, and relationship management.  Comply with United Therapeutics Standard Operating Procedures re. Speaker Programs
• Establish and maintain relationships with current and future thought leaders by working with MSL team to engage in discussions related to publication concepts and advisory boards and responding to grants request and CME educational endeavors.  Primary responsibility is to augment such efforts by members of MSL team by working with them to achieve objectives
• Lead medical / scientific training and support function for key internal stakeholders (CRA, field sales, marketing, etc. Manage project work related to Medical Affairs activities and as assigned by the Senior Director/Director, Medical Affairs, including participation in building out of departmental infrastructure (eg, contributing to SOPs) and helping to realize departmental work stream efficiencies
• Respond to unsolicited requests for information that are beyond the scope of that which is approved for promotional use while adhering to United Therapeutics policy on the dissemination of scientific information
• Approximately 5-10 field-based direct reports (advanced-degreed professionals). Lead performance management efforts with assistance from Director/Sr. Director of Medical Affairs and take responsibility for team performance in relation to objectives.

Requirements

• Advanced scientific or clinical degree (Pharm D., Ph.D., NP, MD) required
• 8+ years working in the biotech / pharmaceutical industry (or appropriate clinical setting) or 2+ years working as an MSL or 3+ years in PAH.  Prior management experience preferred.
• Microsoft Excel, PowerPoint, and Word
• Able to travel at least 60%
• Demonstrated outstanding ability to effectively communicate verbally and in writing scientific and medical information to a diverse audience of both internal and external personnel in small and large audience setting.
• Strong team, leadership, planning, communication, and organizational skills
• High energy level, self starter
• Ability to work independently
• Passion for consultation/teamwork
• Exquisite attention to detail

Qualified candidates please click here to apply!

EOE

Date:

August 18, 2010

Title:

Associate Manager, Sales Operations

Job Type:

Full-Time Position

Job Category:

Commercialization

Location:

Research Triangle Park, NC

Experience Required:

3 years Sales/Sales Operations experience preferred

Education Level:

BS/BA

Role Purpose/Position Overview

The Associate Manager, Sales Operations will be the key day to day interface between the sales organization and the RTP office staff.  This individual will ensure the streamlined operation of the sales organization through both management and functional responsibilities.  Manages the operational sales activities for UT, including the management and coordination of the overall strategy planning, organization and communication to deliver a high level of employee achievement, satisfaction and customer support with emphasis on efficient sales management, continuous improvement and cost reductions.

Key Accountabilities/Responsibilities

Work with the Director of National Sales to complete forecasts, analyze financial results, resolve operational problems and drive area compensation plan and quota implementation.

Serves as liaison with various functional departments (HR, Finance, Marketing, Supply Chain, etc.) to develop and implement programs and resolve problems, provide program support as required, and participate in managing programs impacting the entire sales organization.

Manage recruitment process for Sales and Marketing business units.

Drive salesforce.com usage and compliance to ensure accurate reporting at all levels of the organization.

Field Program Management and Reviews
Work with RBDs to develop and allocate account-based and territory region sales plans.
Participate in Business Reviews and Operational Planning.
Prepare quarterly reviews and other analyses.
Provide HQ and Field management with information and analysis as requested.

Interaction with Field Operations
Ensure compliance with UT and Sales Operational guidelines relating to rules of engagement, compensation, account and territory assignments, HR issues, etc.

Develop and communicate best practices to regions relating to sales, service, and other functional areas.

Sales Compensation
Assist with implementation of compensation and incentive programs. Administer compensation components in the field to ensure compliance with plans, and research issues related to compensation.

Work with field and RBDs and Training to develop contest/incentive rules, rollout plans, and implementation. Also, develop and administer Regional recognition programs.  Manage the Sales Incentive Points Program database. 

Serve as the central point of contact for all field-based questions/requests.  Position will develop, within the first 90 days, a web-based portal (similar to an IT Help Ticket system) to ensure that all requests are categorized and prioritized, and handled on a timely basis. 

Manage all of the commercial compliance requirements for State and/or Federal reporting purposes through the collection and reporting of specific data/expenditures, as dictated or directed by the Government Affairs Department.

Manage and control all department training files.  Provide certifications to CPS team members for hospital access as necessary.

Coordinate and collaborate with Regional Sales Directors to assist and support the organization of regional sales meetings (including, but limited to, securing hotel contract, meetings materials, etc.). 

Train new CPS on key processes (including but not limited to Plan 365, materials ordering, Runzheimer, Concur, Halogen, UT University, Vendor Mate, etc.)

Spend 10%-15% in the field with the sales representatives to assess and communicate back the methods and support items that will improve service offering.

All other duties as required.

Requirements

BS/BA and 3+ years experience in sales or sales operations.

Advanced computer proficiency with systems and with MS Office Suite of products (Word, Excel, Access, PowerPoint and Outlook). 

Proficiency in using web-based and data entry systems (e.g., Runzheimer, EZ Labor, SAP, etc.)

Must be able to travel 20%+ without restriction

Proven ability to work in a fast-paced environment supporting marketing and remote sales reps

Positive attitude and demeanor, flexibility and adaptability in working style

Excellent verbal and written communication skills 

Excellent multi-tasking capabilities and skills

Qualified candidates please click here to apply!

EOE

Date:

July 27, 2010

Title:

Clinical Records Manager

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Research Triangle Park, NC

Experience Required:

8 + years relevant experience

Education Level:

BS/BA, Advanced degree preferred

Role Purpose/Position Overview

The Manager of Clinical Records will manage clinical records, provide a strategy for the efficient and compliant storage, retrieval and protection of clinical records in both physical and electronic forms, including records stored at offsite facilities, and records stored in electronic repositories.

• Offers expertise and support for the Company's disaster preparedness and business continuity.
• Manages the physical and electronic collections of clinical records, ensuring that all staff effectively perform their duties so that all records are accurately catalogued and indexed, filed, and retained, and can be readily located. Ensures that compliance, quality, and budget requirements are met.
• Maintains positive relationships with all functional areas of the Company in order to make continued progress toward seamlessly integrating records management practices into all key business processes.

 

Key Accountabilities/Responsibilities

Records Management:

• Designs, develops and implements processes and procedures for filing, retrieving, storing, preserving, and protecting of clinical records. Collaborates with other departments where such procedures/processes overlap.
• Ensures that all records, both physical and electronic, are accurately catalogued and filed. Ensures that the locations of all physical records are are accurately captured and that all records can be readily retrieved.
• Establishes a quality oversight process for the retrieval and processing of Clinical Records.
• Manages contract workers.
• Conducts facilities planning by reviewing short- and long-term resource and space requirements to identify and evaluated possible options for on and off site locations.
• Collaborates with functional groups within the Company to develop, implement and maintain a disaster preparedness and business continuity program.
• Identifies and establishes goals and objectives for the Clinical Records function, to support the overall goals of the Company.
• Maintains state-of-the-art understanding of the field, through review of published materials, attendance at industry meetings, and completion of relevant coursework/seminars. Analyzes information from such endeavors to determine applicability to current and future needs of the Company.
• Other duties as may be assigned from time to time to ensure consistent and compliant operations.

Staff Management:

• Manages staff that performs the administrative and technical duties to support this position. May prepare job descriptions, interviews and selects candidates, manages performance, and coaches staff in carrying out their duties in conformance with company policies, procedures, and guidelines. Empowers staff through leadership and training to maximize their potential and create a positive work environment.

 

Requirements

• BA/BS degree, preferably in information management, library science, or similar records-related field. A Master's degree is a plus.
• 8+ years experience in the Records Management field, including 4+ years experience using electronic records management systems, with progressive experience managing active, inactive and archived records, analyzing business processes, and developing and implementing Records Management policy and procedures.
• 5+ years experience working in a pharmaceutical or other highly-regulated corporate environment, with significant, and increasingly independent, interaction with the various functional units of the corporation to design and develop record-keeping systems, policies and procedures.
• Broad understanding of business processes in a wide variety of functional areas within a large, international pharmaceutical company, and the ability to translate the records management needs of those business processes into clear and concise terminology, logical and hierarchical arrangements of records types and series, and clear and effective procedures for filing and managing both records and non-records.
• 2+ years direct supervisory/managerial experience, including interviewing, hiring, managing performance, administration of salaries, and coaching employees in their career development.
• English, fluency in second language is a plus.
• Solid working knowledge of word processing, spreadsheet, email and presentation software (MS Office Suite). Background in EDC and CTMS systems desirable.
• 5%-10% travel required (overall). May fluctuate up or down relative to the status of a given project.

Other Skills/Qualifications Required:

• Excellent attention to detail, strong critical thinking and problem solving.
• Excellent organizations, time management and project management skills.
• Ability to interact and communicate effectively, both verbally and in writing, with colleagues and management, both within and outside clinical operations, including upper management, vendor personnel, and clinical investigators and site personnel.
• Strong working knowledge of GCP/ICH regulations and guidelines.
• Experience and comfort in working both independently and as part of a multifunctional team.
• Proven organizational skills and strong ability to prioritize workload.
• Commitment and ability to handle high workloads, demanding situations, and deadlines.
• Ability to proactively identify potential issues and formulate potential course(s) of action.

 

Qualified candidates please click here to apply!

EOE

Date:

August 04, 2010

Title:

Clinical Training and Standards Associate I/II

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Research Triangle Park, NC

Experience Required:

4 years relevant clinical research experience

Education Level:

BA/BS degree, preferably in health or biological sciences

Role Purpose/Position Overview

To support the Global Clinical Quality, Training and Standards department with the management of training matrices, materials and delivery.  Additionally, this position will assist with development and management of Clinical Standard Operating Procedures (SOPs) and quality metrics.

Key Accountabilities/Responsibilities

• Coordinate the production of regular project status update reports on adherence to Role Based Curriculum, Clinical training requirements and Quality Management Plan
• Capture department metrics and assist in data analysis
• Develop tools to track adherence to department Inspection Readiness program – including Role Based Curriculum, Clinical training  requirements and Quality Management Plan
• Author and revise SOPs, Policies and associated forms
• Support Clinical by tracking and facilitating the development of SOPs, Policies and associated forms
• Track training requests and facilitate the conduct of clinical training
• Support GxP Training with updating and maintaining Learning Management System (LMS) with Clinical requirements including processing course descriptions, submission of clinical training materials and recorded presentations
• Responsible for the content management of clinical materials within the LMS
• Organize department meetings, training activities and presentations
• Participate and represent the department on various department teams and task forces
• Track and manage Inspection Readiness program including maintaining schedule for periodic Quality Control visits by the Manager, Clinical Quality Control and assisting in tracking of audit findings from other UT groups (QA) or external groups (regulatory authorities)
• Maintain document lifecycle tracking for Clinical including; SOPs, clinical forms, best practice documents.
• Maintain training schedule and repository for materials
• Manage department files and those within the Document Management System.
• All other duties as assigned 

Requirements

• BA/BS degree, preferably in health or biological sciences
• 4 years relevant clinical research experience
• Strong knowledge of regulatory and clinical practices (GCP, ICH)
• Strong communication skills
• Knowledge of monitoring and clinical trials with an emphasis on adherence to SOPs and Quality Management Plans
• Effective time management and organizational skills.
• Attention to detail and accuracy in work.
• Ability to work independently
• Strong customer service orientation.
• Good written and verbal communication skills
• Creative problem solving
• Strong computer skills including proficiency in use of the Microsoft suite of applications.  Prior use of a Learning Management System (LMS), Document Management System and web conferencing is a strong plus.

 

Qualified candidates please click here to apply!

EOE

Date:

August 30, 2010

Title:

Director, Quality Systems and Compliance

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

8+ years progressive management experience in a cGMP compliance role

Education Level:

M.S. perferred in Chemistry, Life Science or Engineering

Role Purpose/Position Overview

Direct the RTP Quality and Compliance Groups for adherence to cGMP requirements, including FDA, EU and Japanese requirements, as applicable. 

Key Accountabilities/Responsibilities

• Direct the preparation and review of Quality Systems, SOPs and Protocols for the RTP manufacturing facility
• Hire, train and manage Quality and Compliance staff for the RTP facility.
• Support Research & Development and production groups, including process validation at RTP facilities.
• Coordinate GMP activities with other UT facilities
• Lead and manage regulatory agency and other audits/inspections of RTP.
• Oversee GxP training activities and management for RTP staff.
• Manage the complaint process for RTP
• All other duties as assigned

Requirements

• 8 + years progressive management experience in  a cGMP compliance role
• Working knowledge of oral tablet manufacturing and quality systems
• Working knowledge of FDA and EMA cGMPs required. Working knowledge of Japanese cGMP a plus
• Experience in investigational and commercial manufacturing and distribution
• Experience in regulatory agency inspections
• Working knowledge of FDA and EMEA device compliance regulations a plus
• Experience in small molecule drug analysis is desirable with a minimum of 8 years experience in GMP pharmaceutical laboratory supervision/management. 
• Experienced in departmental budgeting
• Instrumentation experience and expertise in HPLC, GC, UV/VIS, FTIR
• Experience in analytical method development/validation and lab method transfer protocols is required
• Experience conducting training in current good manufacturing practices (cGMP) is required. 
• Must be experienced in lab and manufacturing equipment qualification (IQ,OQ, PQ) protocol review, writing and application. 
• Experienced in departmental budgeting
• Excellent verbal and writing communication skills are required.  Must be able to communicate effectively in English and write/enter data legibly in notebooks and laboratory documents, where necessary.  Must be able to effectively communicate across disciplines with managers, directors and senior management.
• Good computer application skills required with expertise in Word and Excel. 

Qualified candidates please click here to apply!

EOE

Date:

August 30, 2010

Title:

Director, Quality Systems and Compliance - Devices

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

8-10 years management responsibility, 5 years exp in medical device industry or equivalent experience

Education Level:

M.S. or higher, degree in Life Sciences preferred

Role Purpose/Position Overview

Responsible for the design, implementation and documentation of policies and procedures that ensure compliance with the quality system regulations as set forth in 21 CFR 820 and relevant ISO requirements. Guide the United Therapeutics and vendor medical device groups for adherence to Quality System Regulations.

Key Accountabilities/Responsibilities

• Oversee the device product release function
• Write, review and assist with regulatory filings and responses
•  Lead FDA and Notified Body units and responses
•  Investigate customer complaints to determine root cause and appropriate corrective action
• Lead the CAPA system
• Define the QA function and SOPs; Ensure the quality system infrastructure is established/ maintained in accordance with current applicable regulations, United Therapeutics policies and procedures.
• Lead the Quality Assurance Department in providing support for a wide variety of medical device design and manufacturing projects, both as a manager and technical contributor
• Serve as Management Representative for all audits and inspections.
• Maintain FDA and ISO 13485 registration, ISO 14971 certification and QSR (GMP) compliance.
• Routinely evaluate the existing quality system; Set future direction to improve product/process quality
• Responsible for assuring product quality, safety and effectiveness, and conduct of failure investigations of customer complaints.
• Responsible for timely Corrective and Preventative Actions (CAPA), change control and notification, internal and vendor audits, product release, document control, design control process and design history files (DHF), device master records, etc.
• Establish employee training in QSR and ISO requirements.
• Manage the resources of the Quality Department to ensure staff are selected and sufficiently trained to meet current and future work requirements.
• Manage QA resources, including personnel, equipment, and budget in alignment with departmental and corporate goals
• Responsible for hiring,  training and effectively managing Quality and Compliance staff for the RTP and EU facilities.
• Coordinate quality activities with other UT facilities
• Manage Compliance and QA personnel in US and Europe.
• Manage vendor compliance interactions
• All other duties as assigned

Requirements

• Knowledge of Good Manufacturing Practices (GMP), applicable Quality System Regulations, ISO 13485:2003
• 8-10 years of progressive management responsibility with at least 5 years in the medical device industry or equivalent experience
• Must possess quality systems/compliance experience
• Working knowledge of FDA and European (e.g., England, Germany) device compliance regulations
• Experienced in departmental budgeting
• Familiarity with combination products, proposed regulations and requirements
• Excellent verbal and writing communication skills are required.  Must be able to communicate effectively in English and write/enter data legibly in notebooks and laboratory documents, where necessary.  Must be able to effectively communicate across disciplines with managers, directors and senior management.
• Good computer application skills required with expertise in Word and Excel. 
• Ability to travel up to 50% , domestic and international

Qualified candidates please click here to apply!

EOE

Date:

September 02, 2010

Title:

HR Assistant- Parttime

Job Type:

Part-Time Position

Job Category:

HR

Location:

Research Triangle Park, NC

Experience Required:

At least 1-2 years HR experience

Education Level:

Bachelor’s Degree preferred

Role Purpose/Position Overview

The HR Assistant will provide support to all HR initiatives to include but not limited to employment, compensation, benefits, employee relations, stock options, policy and program matters.  The position is 20 hours per week and offers a flexible schedule.

 

Key Accountabilities/Responsibilities

Responsibilities include:

• Process new hire paperwork and benefits; ensure accurate entry of employee information into relevant databases (benetrac, ADP, halogen)
• Assist with the recruitment of new employees; schedule meetings; assist with interview scheduling and coordination
• Post jobs on recruiting sites and UT website
• Administer the contracts and the contract approval process including file management
• Process payroll changes
• Track any changes and update forms for company including employee handbook
• Arrange for distribution of necessary materials to employees
• Proofread and create policies and procedures and other documents
• Order HR/training supplies
• May have responsibility to update companywide organizational charts and upload them to the intranet
• Complete employment verifications for employees
• Conduct reference checks for prospective employees
• Process all term paperwork
• Other duties as assigned

Requirements

Requirements for the qualified HR Assistant:

• Self Motivated
• Able to prioritize a multi-tasked workload
• Possess strong organizational skills
• Exhibit excellent communication skills
• Adaptable
• Detail oriented

Qualified candidates please click here to apply!

EOE

Date:

August 05, 2010

Title:

Manager, Clinical Quality

Job Type:

Full-Time Position

Job Category:

Quality

Location:

Research Triangle Park, NC

Experience Required:

Ten years in biopharmaceutical research & development or CRO

Education Level:

Requires a bachelor’s degree; scientific related field preferred

Role Purpose/Position Overview

The Manager of Clinical Quality will lead and manage department inspection readiness for clinical departments; will manage and maintain metrics on department adherence to regulatory requirements and department standards to ensure department quality; will develop and oversee a Quality Management Plan (QMP) for clinical functions; will conduct Quality Control visits to determine compliance with SOPs, ICH/GCP, applicable regulations, and study protocol and provide feedback on findings with critical attention to addressing issues with solution-oriented proposals.

Key Accountabilities/Responsibilities

• Develop and manage a Clinical department Inspection Readiness Plan.
• Develop, implement and monitor adherence to clinical department QMPs including the quality oversight of vendors and contractors assigned to clinical oversight of studies.
• Define, develop, implement and continually improve quality control measures within the Monitoring Program, including a list of standard quality checks to be performed as part of the Performance Assessment Visits (PAVs) and Quality Control (QC) visits.
• Develop and maintain guidelines for the conduct of Performance Assessment Visits (PAVs) and Quality Control (QC) Monitoring Visits to assess study conduct and overall site performance .
• Collect and analyze qualitative and quantitative results from PAVs and QC visits and report results to management team.
• Conduct periodic QC monitoring visits with a sample of sites and monitors and liaise with management on project compliance concerns or trends.
• Interact with CRA Managers to determine a plan for PAVs for each monitor on a routine or as needed basis PAVs according to plan.
• Develop a tracking system to ensure regular PAVs are done for all monitors.
• Communicate concerns or progress and resolution of issues resulting from PAVs and QC visits to appropriate clinical staff.
• Work with CRA Managers and Monitors to address concerns and resolve issues through on-site assessment and training when potential compliance issues are identified.
• Conduct QC assessments to verify selected study documents are complete and correct.
• Provide on-site training for monitoring staff as needed.
• Collaborate with Clinical Training and Standards in the development and presentation of continuing education sessions based on QC visit and PAV findings.
• Develop reports for management to highlight concerns and action plans .
• Collaborate with GCP Compliance/QA to identify trends from GCP Compliance/ QA site audits and make recommendations to management to improve overall findings.
• Identify need and assist with implementation of process and efficiency improvement
• Support clinical team in preparing for external audits.
• Support clinical team by providing input into the generation of timely and appropriate audit responses.
• Provide staff support by answering questions or providing advice on ICH, GCP, SOPs, local regulations and guidelines.
• Maintain strong working knowledge of SOPs as well as ICH, GCP, local regulations and guidelines.
• All other duties as required.

Requirements

• This position may have direct reports.
• Requires a bachelor’s degree; scientific related field preferred.
• Ten years in biopharmaceutical research & development or CRO.
• Eight years as a CRA and/or Clinical Manager in the biopharmaceutical industry preferred.
• Four years experience in a staff leadership role.
• Experience with developing SOPs and department processes.

Qualified candidates please click here to apply!

EOE

Date:

August 03, 2010

Title:

Manager, Clinical Training and Standards

Job Type:

Full-Time Position

Job Category:

Clinical Operations

Location:

Research Triangle Park, NC

Experience Required:

8 + years experience

Education Level:

BS Required

Role Purpose/Position Overview

The Manager of Clinical Training and Standards will identify, lead and manage training needs of clinical staff.  This position will design and deliver quality training to clinical staff including Standard Operating Procedures (SOPs), GCP, regulatory updates and process changes.  This role is also responsible for managing and maintaining clinical Standard Operating Procedures (SOPs) and to assist in the development of clinical procedures and processes.

Key Accountabilities/Responsibilities

• Deliver training relating to Clinical SOPs, ICH, GCP and regulations.
• Facilitate training on clinical protocols, study procedures and therapeutic areas
• Design, develop, implement and evaluate clinical training  programs within Global Clinical departments:
  • To qualify new hire monitors to perform assigned functions independently
  • To ensure clinical staff stay knowledgeable of Clinical SOPs, ICH/GCP and regulations
  • To address training needs identified by clinical QC/QA activities
• Evaluate the GCP training program for effectiveness and completeness, making revisions to the program as necessary.
• Work with clinical department heads to establish department specific training matrices/curriculums.
• Conduct periodic needs analyses to determine training gaps/needs of clinical staff ; make appropriate recommendations for resolution/revision and implement training to provide continuing education for clinical staff
• Manage the development and maintenance of departmental training reports and metrics
• Assist in the implementation of new training technologies and systems and leverage training and training solutions developed within UTC
• Review clinical training records for completeness.
• Author and/or revise Clinical SOPs and ensuring consistency with common practices
• Serve as the Clinical department point of contact for SOPs requiring clinical input
• Collaborate with Clinical management and international counterparts on the development of standard procedures, processes and associated documents
• Maintain and facilitate the distribution, review, approval and training on Clinical SOPs.
• All other duties as required

Requirements

• At least 8 years of relevant pharmaceutical industry experience
• An in depth understanding of GCPs and at least three years of training experience.
• Experience with developing SOPs and department processes.
• Experience with quality assurance audits preferred.
• Experience with training and mentoring clinical research staff
• Working knowledge of word processing, spreadsheets, email software and training software and authoring programs (e.g. Articulate, Captivate, Lectora).
• A working knowledge of Learning Management Systems (LMS), document management systems and web conferencing.  Previous experience using Compliance Wire a plus.
• Strong working knowledge of US FDA, EU and GCP regulations is required. 
• Must be detail oriented, self motivated, organized and have the ability to prioritize work. Additionally, must be able to work independently and as part of a multi-functional team, being able to handle high workloads, stressful situation and deadlines. 
• Strong communication and presentation skills also required.
• Must be able to communicate effectively, both written and orally with colleagues, management and senior management - cross-functionally. 
• Must have the ability to present formally within area of expertise to a diverse audience.  Additionally, must be able to communicate with regulatory agencies, when applicable.

Qualified candidates please click here to apply!

EOE

Date:

June 06, 2010

Title:

Senior Director, Marketing

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Research Triangle Park, NC

Experience Required:

10-15 + yrs relevant experience

Education Level:

BS/BA, MBA Required

Role Purpose/Position Overview

To lead the marketing team in support of assigned products to maximize contribution to company revenue goals.

Key Accountabilities/Responsibilities

• Develop and implement forward thinking marketing plans for UT products to ensure forecasts are achieved
• Develop and manage the annual revenues requirement and expense constraints
• Oversee the optimal mix of promotional and educational channels (medical education, CME, promotional, etc.) for each product in the portfolio within organizational, regulatory, and legal boundaries
• Develop comprehensive pre-launch commercial planning and launch logistics plans for our late stage development pipeline
• Working in close consultation with sales management, develop, effectively communicate, and drive alignment and consistency of branding, marketing messages, and product positioning statements
• Ensure continuity of marketing strategy, core messages, branding, etc. across all markets (US, ROW)
• Collaborate with medical affairs in strategic alignments of Phase IV trial strategy and publication plans.
• Assimilate qualitative and quantitative market data to generate a deeper understanding of the customer, market trends, needs gap analysis
• Develop, utilize, and synthesize novel market research to support strategic decision making across all potential commercial opportunities
• All other duties as assigned

Requirements

• BA/BS, MBA required
• 10 + yrs pharmaceutical industry experience
• 3 + yrs sales experience required
• 5 + yrs marketing experience required
• Experience developing and flawlessly executing comprehensive marketing plans, tactics, and pre-launch commercial strategy
• Strong understanding of the dynamics surrounding pricing and reimbursement
• High level of proficiency using Microsoft Word, PowerPoint and Excel. Independent expert use of these applications is required
• Ability to interact effectively at all levels of the business
• Ability to work effectively as both an operational and strategic leader
• Demonstrated leadership, team building and motivation skills
• Experience managing departmental budget to high level of detail
• Ability to travel 30 - 40 %
• Strong interpersonal skills
• Ability to lead and inspire commitment and confidence
• Effective written and oral communication skills
• Strong attention to detail and accuracy in work
• Ability to multitask and prioritize in a rapidly moving environment
• Hands-on, team player mentality
• Commitment and ability to handle high workloads, demanding situations, and deadlines.

Qualified candidates please click here to apply!

EOE

Date:

June 11, 2010

Title:

Bookkeeper

Job Type:

Full-Time Position

Job Category:

Administrative

Location:

Melbourne FL

Experience Required:

5 years direct experience

Education Level:

AA, Accounting or related required

Role Purpose/Position Overview

The Bookkeeper is responsible for the following functions: AP, AR, Inventory and Cash Receipts

Key Accountabilities/Responsibilities

Accounts Payable (AP) -

• Issuing Purchase Orders
• Processing invoices and expense reports
• Entering accounts payable in accounting software
• Preparing bimonthly AP reports for management approval
• Printing checks from the accounting software and mailing to vendors
• Filing and organizing vendor files
• Maintaining vendor relationships
• Printing monthly AP ledger reports
• Maintaining vendor W9s
• Filing annual 1099s
• Filing monthly sales and use tax returns
• Updating vendor information in accounting software as needed

Accounts Receivable (AR) -

• Verifying direct billing information
• Entering direct billing in accounting software
• Printing direct bill invoices from the accounting software and mailing to customers
• Filing and organizing customer invoice files
• Printing monthly AR ledger reports
• Updating direct customer information in accounting software as needed

Inventory -

• Counting inventory monthly
• Preparing monthly inventory reconciliations
• Preparing offsite inventory reconciliations
• Updating inventory part information in accounting software as needed
• Preparing inventory reports as needed

Cash Receipts

• Post daily deposits from Medicomp’s lockbox and other sources into financial accounting software

Other

• Preparing AP, AR, fixed asset and inventory information for quarterly and annual audits
• Establishing strong relationships with department managers as needed to accomplish assigned duties
• Maintaining strict adherence to accounting policies and controls
• Assisting with accounting or administrative projects as delegated

All other duties as required.

Requirements

• At least 5 years of full-cycle A/P, A/R and bookkeeping experience.
• Excellent command of English, both written and spoken.
• Word, Excel, Outlook, Accounting software - SAP required
• Strict compliance with all policies and procedures and internal controls.
• Must be detail-oriented and have excellent written and verbal communication, analytical, interpersonal and organization skills.
• Must be a self starter, comfortable with managing projects and deadlines.
• The successful candidate will join a strong and growing company that offers a rich benefits package and bonus plan.

United Therapeutics Corporation is a publicly traded biotech company headquartered in Silver Spring, Maryland. We are incorporated in Delaware and listed on the NASDAQ stock market under the symbol "UTHR". This position is located at our subsidiary company in Melbourne, FL, Medicomp, Inc. For more information, please visit our websites: www.unither.com and www.medicompinc.com

Qualified candidates please click here to apply!

EOE

Date:

August 30, 2010

Title:

NAM - Government Account Manager

Job Type:

Full-Time Position

Job Category:

Sales & Marketing

Location:

Home office – US

Experience Required:

3+ years combined Bio/Pharmaceutical and device sales experience

Education Level:

Bachelor's Degree Required; Advanced Degree or Life Sciences preferred.

Role Purpose/Position Overview

The Government Account Manager (GAM) role is a development opportunity with the Managed Markets team at UT. The GAM’s primary purpose is to drive formulary access and preferred product placement by assigned Fee For Service Medicaid States, Medicaid HMO’s and a limited set of regional commercial payers. Other specific Government payers may be assigned to the GAM. The GAM ensures access and reimbursement of United Therapeutic’s current and future products, while cultivating and managing assigned Medicaid relationships with assigned Medicaid program across the U.S. The GAM is a partner and resource to field sales on all managed care pull-through and reimbursement initiatives.  

Key Accountabilities/Responsibilities

• Initial focus (75% of time) on Medicaid formulary uptake for Adcirca and Tyvaso, and 25% of their time on other high priority regional payers as assigned.
• Establishes UT’s relationships with key Fee For Service Medicaid States, Medicaid HMO’s and assigned regional commercial payers.
• Successfully manages and drives formulary and reimbursement uptake for all UT and LungRx brands
• Identifies, develops, and implements the payer business opportunity; partners, communicates with sales teams and directs pull through for relevant UT and LungRx U.S. sales teams.
• Develops and manages productive business relationships with assigned Medicaid State pharmacy program administrators.
• Optimizes UT managed care sales opportunities, while maximizing Return On Investment and market competitiveness.
• Develops and executes product aligned payer business plans that ultimately drive revenue growth and company market share goals.
• Advances UT and LungRx field sales teams’ managed care savvy and related sales effectiveness by  providing timely managed care and reimbursement education with appropriate direction and follow up support.
• Educates payers on the clinical and economic benefits of current and future UT products by partnering with the MSL team.
• Makes formal business and product presentations to payer and appropriate internal management audiences.
• Drives new product uptake, formulary access and preferred formulary positions v. competitors where it makes business sense.
• Interacts with Specialty Pharmacy reimbursement staff.
• Directs MCO pull through messaging and translating payer opportunities into increased sales.

Requirements

PREFERRED SKILLS, KNOWLEDGE, EXPERIENCES include:

• Minimum of 3 years of successful sales performance and territory management.
• 3+ years combined Bio/Pharmaceutical and device sales experience (Required).
• 2+ years current experience in pulmonary arterial hypertension (Preferred).
• Strong problem solving skills required.
• Strong interdepartmental communication skills required.
• Prior sales management experience (Desirable).
• Prior managed care training and certification course highly desirable.
• Has strong current relationships with relevant Specialty Pharmacies (Required).

Qualified candidates please click here to apply!

EOE