Vertex Pharmaceuticals Inc. is seeking a Senior Manager – Contract Development to join the Managed Markets team.  This individual will be responsible for facilitating and managing the managed care contracting process, developing business cases supporting the proposals, assist in the negotiation of contract terms and pricing with customers, and reviewing contracts for legal content and for compatibility with Company business processes and policies. 

The successful candidate will also review credentialing packets and applications to be sent to managed care organizations, state and government accounts, coordinate the contract process with Field Sales, Operations, Third Party Payers and Legal, and provide reports and analysis as needed.  He/she will work cross functionally to ensure contracts are reviewed and executed in a timely and accurate manner, meeting all contractual deadlines, adhering to all SOX controls, and developing effective processes to facilitate contract management.  He/she will collaborate with peers including other Contract Development Managers, government pricing personnel, and rebate operations. The candidate will provide insight and intelligence to the forecasting/accruing process, working with Finance, Accounting, Budgeting and other stakeholders.  The successful candidate will have an ability to thrive in an environment of rapid change; work effectively within cross-functional teams; will be highly resourceful; able to deliver strong results; have a passion for operational excellence, and possess strong communication and analytical skills.

Key Responsibilities:
- Coordinate contract development through interaction with Managed Care Business personnel including NAMs, RAMs and other field management, Legal, and the Senior Director, Pricing and Contracting to ensure contracts are prepared accurately and in a timely manner.
- Assist the Managed Care Business Group personnel (NAM's/RAM's), Contracting Directors, Account Directors and other headquarter departments in working through language changes to contracts as they are negotiated.
- Develop, in conjunction with Field Sales, business cases that demonstrate the rationale and ROI supporting the contract proposal.
- Assist in price negotiations; approve contract terms and conditions with managed care accounts.
- Manage the implementation and ongoing monitoring and management of new and existing contracts.
- Manage, monitor and maintain the company policies and procedures.
- Assist the Government Pricing Manager in determining potential Best Price, and communicate all new and concluded contracts to the pricing and administration team.
- Collaborate with Rebate Operations to ensure all contracts are established correctly within the CARS system.
- Communicate with Managed Markets leadership with regards to contract performance.
- Create tools to facilitate the contract review and approval process.
- Communicate with plans, as necessary, regarding disputed rebate claims.
- Establish strong working relationships with other internal and external customers to support contracting excellence.
- Work closely with the Government Pricing Manager, peer Contract Development Managers, RAMs, NAMs and other commercial team members to ensure strategic alignment and execution of contract development and strategy.
- Provide payer knowledge into key accrual/forecast and planning teams including Accounting, Finance, Contracting, and brand teams.
- Perform all company business in accordance with regulations, company policies and procedures.

Minimum Qualifications:
- A Bachelor’s degree
- 5+ years of experience in the pharmaceutical and/or biopharmaceutical arena, including managed markets operations.

Preferred Qualification:
- An MBA
- Previous experience managing biopharmaceutical pricing, reimbursement, and access related projects.
- Strong analytical, problem-solving and decision-making skills.
- Demonstrated ability to collaborate across functional areas to drive results.
- Knowledge of CARS, with experience in pharmaceutical contracting.
- Familiarity and working knowledge of the government pricing regulations.
- Ability to work under tight timelines; possesses a high level of energy, initiative, and ability to multi-task.
- Ability to successfully interact with Management and customers.
- Excellent communication skills (both oral and written), with the ability to communicate across multiple functions and levels.
- Ability to remain current with new regulations and rebate programs.
- Working knowledge of managed customer segments (private and governmental).
- A strong understanding of the legal and regulatory environment for pharmaceutical products.
- An entrepreneurial spirit and ability to develop creative solutions to complex problems.
- Ability to manage complexity and ambiguity in a highly matrixed environment.
- Expertise in CARS and or other contracting tools as well MS Office products; Word, Excel and PowerPoint.
- Embody the Vertex Core Values of Uncompromising Commitment to Patients, Fearless Pursuit of Excellence, Innovation is Our Lifeblood, and “We” Wins
- Effective communication skills, both verbal and written

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

The Medical Director will have the opportunity to work on a compound with known efficacy with multiple targeted disease indications. He/she will serves as protocol author, Vertex Medical Monitor and data reviewer for Clinical Trials, ensuring compliance with GCP regulations, data integrity and subject safety.  Works on multiple Trials or more than one Program at a time, encompassing Phase I, Phase II and/or Phase III studies.

Key Responsibilities
- Develops Clinical Protocols, Investigator’s Brochures and clinical development plans (in coordination with Clinical Program Manager) with emphasis on scientific and safety matters, with minimal guidance
- Represents Vertex to outside medical/scientific experts in the development of the clinical protocols, solicitation of input and opinion, and presents at conferences and symposiums
- Serves on the Clinical Sub-Team and represents Clinical Development on Core Teams
- Acts as Program physician and assumes responsibility for scientific and clinical aspects of Program including in depth data review and clinical study reports
- Provides Clinical Development input to the Development Disease Area Team
- Provides Clinical Development input to the Global Safety group including Safety Reviews
- Participates in the preparation of regulatory documents including IND safety reports and annual reports and the clinical section of IND’s and CTA’s; provides scientific and clinical input and content review
- Utilizes novel and creative methods to resolve clinical development problems independently
- Acts as liaison between clinical development department and internal regulatory affairs for assigned programs
- Interacts with regulatory agencies as needed on protocol and program issues
- Mentors Clinical Program Managers as needed

Minimum Qualifications
- M.D., or ex-US equivalent medical degree
- 4-8 years of industry clinical development work experience
- Board certified in Internal Medicine or similar medical specialty with subspecialty training
- Excellent oral and written communication skills
- Substantive knowledge of biostatistics, clinical pharmacology and pharmacokinetics
- Complete understanding of the drug development process
- Keep abreast of all regulatory updates and changes and disseminates information effectively and appropriately

Preferred Qualifications
- Training or experience working in Dermatology, Rheumatology, Gastroenterology, Pulmonary, Allergy/Immunology

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

To Apply for this position, please CLICK HERE

Temp. Contract, 6+ Months

Under the supervision of a Biostatistics project leader, the Temporary Senior Biostatistician is responsible for the design, development and evaluation of the technical and statistical infrastructure. This individual will also be responsible for the conduct and evaluation of clinical trials, including the coordination of all related areas/activities.

Key Responsibilities:
- Prepare statistical section of study protocol and any necessary amendments
- Perform exploratory analysis of past studies and conduct examination of literature for sample size estimation
- Prepare randomization plan and related documentation, as well as SAP and TFLs design including in-text tables and figures
- Provide input to CSR development
- Provide input to CDISC Programming Specification and Statistical Programming Specification (CPS and SPS) development, and review, (e-)CRFs, monitoring, data management, data QC and data validation plans
- Leads team in the areas of experimental design, protocol development, statistical analysis plans and statistical analysis to meet project objectives
- Create and collate statistical section of clinical study reports, INDs, NDAs, and annual reports
- Serve as a contributing member of project teams with Clinical Data Managers, Statistical Programmers, and other MDG management responsible for meeting study objectives
- Independently determine the best methods and techniques in design of complex analysis in support of project objectives

Minimum Qualifications:
- Ph.D. with 3+ years of industry experience
- Master's degree with 5+ years of industry experience

 Preferred Qualifications:
- Experience with immunology compounds
- Ability to work under minimal supervision

Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, rheumatoid arthritis and other life-threatening diseases. Founded more than 20 years ago in Cambridge, Mass., we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist. For more information and to view Vertex's press releases, please visit www.vrtx.com.

VERTEX is an Equal Employment Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status, genetic information or any other status protected by federal, state or local law.

To Apply for this position, please CLICK HERE

The primary function of this position is to support the development of the analytical strategy for new programs, with a focus on the biologics programs.  Included with these activities will be support of outside CMO/CRO organizations that tests samples for Momenta.  In addition this position will be required to actively support the preparation of both the characterization sections and the analtyical sections of regulatory filings. 

Requirements:

• Ph.D. degree in a Analtyical Chemistry or related field
• Strong Analytical Chemistry background with expert level skills in one or more of the following:  characterization and analysis of proteins, implementation of bio-analytical programs in support of product development, working level experience with method development and validation and technical transfer for bio-analytical methods
• In addition, the successful candidate will have excellent communication skills and demonstrated experience with the preparation of analytical CMC sections of regulatory submissions
• Experience in development of comprehensive analytical strategies for product development is required and experience with the preparation of filings for generic products is an advantage.  In addition, experience in working with contract manufacturing sites and contract analytical laboratories is required
• Experience with cross functional teams in a multi-project environment is also required

ARIAD is a Cambridge, Massachusetts-based biotechnology company focused on cancer. We are a cohesive team of talented people from diverse backgrounds with a shared vision: We seek to transform the lives of patients with breakthrough cancer medicines. This is our purpose. This is our passion. This is our promise.

Summary

ARIAD Pharmaceuticals Inc. is seeking an independent and highly motivated associate scientist with a strong background in protein biochemistry, molecular biology and tissue culture to join our small molecule oncology drug discovery team.  The successful candidate will play an important role in expanding ARIAD’s capability and platform in structural chemistry and structure-based drug design and will join an interdisciplinary research group encompassing biophysical chemistry, structural chemistry (X-ray and NMR), computational chemistry and cheminformatics to support our internal drug discovery efforts.

Duties and Responsibilities

• Design and make protein expression constructs in various protein expressing systems
• Purify protein in sufficient quantities for structural and biophysical studies
• Grow baculovirus/insect cells for protein expression and production
• Set up protein crystallization experiments
• Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
• Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization.

Experience and Requirement

• B. S. or master degree in life science related fields
• At least two years of lab experience
• Experience in cellular culture of bacteria, insect or mammalian cells
• Experience in molecular cloning
• Experience in protein purification and characterization (chromatography purification on AKTA systems and protein analysis by western blot, SDS and native gel electrophoresis)
• Experience in protein crystallization or enzymology would be a plus
• Good communication and teamwork skills
• Strong commitment to business ethics
• Understanding of, and experience with, regulatory framework applicable to interactions with HCPs, payers, advocacy and other business partners.

Submitting a resume online at a job site could cause valuable screening information to be missed.

Click here to apply:

http://ariad-openhire.silkroad.com/epostings/submit.cfm?fuseaction=app.dspjob&jobid=224&company_id=16419&version=1&jobboardid=306

ARIAD is an equal opportunity employer. The Company's policy is to afford equal employment opportunities to qualified individuals without regard to race, color, religion, national origin, ancestry, citizenship, marital status, veteran status, physical or mental disability, sex, sexual orientation or age and to comply with applicable laws and regulations. All employment decisions will be consistent with the principle of equal employment opportunity.

To apply, send email with a subject of “Job Code CLAD” to careers@ironwoodpharma.com. Please include a CV and cover letter with your email message.

Position description:

Ironwood Pharmaceuticals is looking for a highly motivated associate level scientist to join the Pharmaceutical Development group. The successful candidate will perform analytical tests and assist in method development under supervision of a senior level scientist, help other analytical scientists with general lab operations.

Responsibilities:

• Perform major analytical test methods for drug substances and drug products on pre-clinical and early clinical stages;
• Assist in analytical methods development under supervision;
• Help analytical development scientists with general lab operations: preparation of solutions and buffers, supply inventory, etc.;
• Act as a data driven, entrepreneurial scientist in a fast-paced, can-do environment.

Requirements:

• B.S. in Analytical Chemistry with a minimum of one, but not more than five years of relevant industry experience;
• Knowledge of analytical principles used for analyses of small molecules and peptides or proteins;
• Experienced with HPLC, GC, UV/Vis spectrometry, as well as wet chemistry techniques;
• Excellent oral and written communication skills.

EMD Serono, Inc. is a leader in theU.S.biopharmaceutical industry. We have more than 1,000 employees throughout the United States. 

DESCRIPTION

As a member of the Global Governance team, this position serves a critical role in enabling effective drug development decision making by preparing decision makers with the basis for GDM program/project value-risk evaluation, portfolio prioritization setting and resource allocation management. High impact strategic operations and communications role supporting GDM portfolio program/project metrics management, analyses and insights.

Act as the voice and face of the team – always presenting with the highest level of engagement, professionalism, courtesy and customer service becoming a trusted member of the function as well as the broader organization.  

• Key interface between decision makers, functional heads, and teams to drive excellence in operational execution of the GDM pipeline in alignment with the divisional strategy through an understanding of the state of pipeline performance 
• Interacts with executives and Research/Development/Commercial (RDC) stakeholders to understand and facilitate analysis, business insights, and reporting needs that provides context and drives effective portfolio decision making for GDM
• Conducts multi-project analyses and derives insights that enables program/project value-risk evaluation, GDM portfolio prioritization recommendations and resource allocation decisions
• Creates or supports presentations and reports that effectively communicate insights regarding the performance of the GDM portfolio (e.g., DPPR, GL Advisory Board, PEC, DOC)
• Ensures that reports reflect the appropriate reference information on each project in the global project portfolio (“single source of truth”)
• Develops, analyzes, tracks and communicates Key Performance Indicators (KPI) for GDM portfolio
• Maintains real time and accurate program/project metrics (e.g., Probability of Success), quantitative and qualitative information that inform the GDM portfolio analyses and stakeholder reports
• Proactively translate performance information into action items to improve operational efficiency and effectiveness of project teams and project deliverables
• Set up, coordinate and lead cross-functional, multi-national and multi-cultural teams to establish new KPIs and measurements supporting improvement processes for projects and functions 

QUALIFICATIONS

• Minimum 8 years experience in a global pharma or biotech organization
• Strong project, portfolio or financial planning and management experience
• College degree in scientific discipline, advanced degree preferred
• MBA preferred
• Fluent English both written and verbal; French/German desirable
• Successful track record within industry-leading pharmaceutical or biotech organization
• Successful track record working with senior executives and teams
• Experience as a consultant is an asset
• Strong problem solving and analytical skills including excel-based modelling and database management
• Experience in supporting governance and decision-making processes within a global organization  

PERSONAL SKILLS & COMPETENCIES

• High customer service mentality
• Professional and pleasant demeanor
• Excellent interpersonal, written and oral communications skills
• High team orientation
• Ability to multitask and to be flexible to work assignments
• Ability to use critical thinking as well as intricate knowledge of the operation of the function to independently set priorities
• Strong organizational skills
• Attention to detail and follow-through a must
• Proven experience and examples of developing and maintaining relationships across functions
• Position requires both domestic and international travel up to 10% of time
• Must be able to be flexible with work schedule in order to accommodate the varying volume of work and requests

**Please note: this position is with EMD Serono in our new Billerica facility.

Manager, Regulatory Affairs

POSITION
The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

DUTIES
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

Basic qualifications:
Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.

Preferred qualifications:
Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired

Interested candidates should send an updated resume in MS Word format to jeff.stone@mpi.com

Manager, Regulatory Affairs

POSITION
The Submission Manager will be an integral member of the Global Regulatory Dossier Management Group. On a daily basis, the Submission Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, and utilizing a wide array of document management, authoring, and publishing tools. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.

DUTIES
Working closely with the Regulatory Leads, the Submission Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.
Plan and manage Regulatory submissions, working with Regulatory Leads to develop and submit filings according to agreed upon processes and timelines.

Drive existing submission processes on multidisciplinary submission teams; develop and implement process change under the direction of Regulatory management.

Identify issues that may delay product or project and recommend appropriate action.

Manage generation and compilation of Regulatory sections of submissions using electronic document and publishing technology.

Apply quality control processes and engage in lifecycle management of submissions to ensure document integrity.

Prepare and maintain templates that meet Regulatory electronic submission standards.

Assist in development and maintenance of our electronic submission capability at Millennium, representing the Regulatory business function on technology teams.

Basic qualifications:
Minimum of 4 years of experience within the pharmaceutical industry and strong submission management and/or project management experience is required. Skill in using desktop applications and proficiency in computer systems and procedures is required.

Preferred qualifications:
Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired. Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired

Interested candidates should send an updated resume in MS Word format to jeff.stone@mpi.com

Commonwealth Sciences, Inc. is a Boston area recruiting firm specializing in life sciences, engineering and green technologies. We work with scientific and engineering professionals at a variety of levels and disciplines primarily in the Biotechnology, Pharmaceutical, Medical Device and Green Technology industries.   We are currently seeking energetic, outgoing individuals to join our growing business as a Scientific Recruiter / Account Manager.

Responsibilities include developing new business with pharmaceutical, biotech, engineering and green technology companies through inside and outside sales activities including lead generation, cold calling, networking and marketing campaigns. Activities require extensive phone work and coordinating multiple activities. Duties also include sourcing and recruiting technology candidates through the internet, networking events, call marketing, job fairs and campus recruiting.  

Commonwealth Sciences offers an ethical and entrepreneurial atmosphere where your independence, creativity and drive can develop and flourish. We invest heavily in the latest recruiting tools and technology to optimize your ability to compete and succeed in a competitive market place. We also offer one of the most lucrative commission plans in the business.  

Qualifications must include a Bachelor's Degree in a technology or business discipline with outstanding communication and interpersonal skills. Candidates must have experience in sales and/or recruiting in the life sciences, engineering, high-tech or staffing industry with a stable and proven track record. Candidates must have a strong drive and work ethic with the ability to operate independently in a fast paced environment. Local candidates are highly preferred.  

Candidates must live local to Norwood MA

Recent Graduates with an interest in technology sales are encouraged to apply.

Email resume to: rick@cwsciences.com  

Commonwealth Sciences, Inc.

www.cwsciences.com

Candidate will be part of an Analytical Development group supporting drug development. Will focus on method development, validation and transfer.    

Requirements:  

BS/MS with 1+ years experience in analytical development focused on small molecules.  

Must have experience with HPLC and dissolution Experience with KF, GC and IC are also required.      

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com  

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Responsibilities:

• Lead clinical protocol development process: responsible author for clinical protocols, amendments and related documents; contribute to medical/scientific input given for the development of trial-related documents and processes; obtain approval from internal review boards. Collaborate with the Medical Directors and investigators to ensure their feedback is adequately integrated into protocol.
• Contribute to the development of clinical sections of regulatory documents like Investigators' Brochures, briefing books, safety updates,IND/NDA submission documents, responses to Health Authorities questions.
• Forecast trial resources needs: accountable for the development, management and tracking of trial budget working closely  with Clinical Trial Budget Managers and OTM Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems.
• Ensure that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are applied to the clinical trial, where applicable.
• Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties; manage interface with external vendors in cooperation with the CRO Management Department.
• Function as local trial leader (LTL) for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments.

Requirements: 

Education: Advanced degree in a health care field is preferred.

Minimum 4+ years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
Experience with clinical data review is essential

Candidates must live local and be a US Citizen or Green Card Holder
Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Responsibilities:

• Responsible for providing operational and program level support for several Phase I/II clinical trials under the leadership of the assigned Lead CTL
• Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality standards. Assigned responsibilities can include development of specific sections of related study documents (eg sections of the lab manual); development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans.
• Maintain appropriate study tracking forms including: enrollment log/trial allocations forms, site and vendor contact lists, drug shipping logs.
• Support Drug Supply Management
• Manage and track, US invoices for third party vendors working closely with the CTL. Process all US third party vendor payments
• Functions as the local trial leader (LTL) for US operational activities including working closely with US Clinical Operations for US study start up meetings and trial agreements in addition to all other US based study start-up activities
• Set up and maintain eTMF tracker in CREDI for all studies. Provide support to CTL to ensure timely completion of eTMF tracker for CSR

Requirements:

Bachelor degree or equivalent education/degree qualification in life science/healthcare required. At least 1 year of involvement with clinical study planning, execution, reporting or publishing activities (either at a local medical organization, investigational site, pharmaceutical company/CRO, or clinical fellowship program) preferred.

Candidates must live local and be a US Citizen or Green Card Holder
Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Responsibilities:

• Support users with routine maintenance of the Clinical Trials Management System - ClinTrack.
• Support final users in entering data into ClinTrack by running training, refresher training and overcoming issues.
• Set up and maintain master data in ClinTrack, as requested by users
• Ensure a correct and timely data entry / update process for ClinTrack and perform updates also on behalf of the data owner
• Provide orientation and guidance on ClinTrack processes, present in SOPs, WIs and related documents
• Support MySites Training and first line support. Provide guidance on MySites accounts
• Provide support to users in running the ClinTrack Reports

Requirements:

Education: Bachelor's degree
Skills 2+ years performing listed duties within a ClinTrack system

Candidates must live local and be a US Citizen or Green Card Holder
Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Looking for a Chemistry Technician to join a research group to perform analytical testing.

Requirements:

BS/MS in Chemistry with 1+ years of research experience in an academic or industry setting performing analytical techniques including HPLC, GC, ion chromatography, etc.

Must also have experience with wet chemistry including titrations and solution prep.

Experience with LabVIEW programming is a plus

Recent graduates with strong undergraduate research experience focused on analytical chemistry are encouraged to apply.

Candidates must live local and be a US Citizen or Green Card Holder
 
Email resume to: jobs@cwsciences.com
 
Commonwealth Sciences is a professional recruiting firm specializing in science, engineering and green technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise,advanced recruiting tools and years of staffing experience. CWS works with a
variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.
 
Commonwealth Sciences, Inc.
www.cwsciences.com

Looking for a candidate to ensure compliance with packaging standards and regulations.

Responsibilities:

-          In charge of proper packaging labels for all products

 -          Train staff on labeling guidelines

Requirements:

BS/MS with industry experience in label proofreading. Knowledge of CFR and CTFA label guide Regulations

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in science, engineering and green technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise,advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Candidate will provide and manage regulatory support to the company in order to obtain marketing authorizations for commercial products, provide input into all stages of the company's development and portfolio products, develop strategies to ensure a complete and rapid development, manage the preparation of Regulatory Documentation, and various other management responsibilities.

Requirements:

BS/MS in scientific field with 5+ years of experience in Pharmaceutical Regulatory Affairs at least 1 of which in a management capacity.
Knowledge of worldwide regulatory procedures and requirements.
Experience providing regulatory input and coordinating with various departments regarding regulatory submissions.
Experience coordinating regulatory procedures such as clinical trials applications, IND submissions and amendments, marketing and manufacturing authorization applications, variations, annual reports, renewals, etc.

Candidates must live local and be a US Citizen or Green Card Holder

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Looking for chemistry/biochemistry candidates to join an environmental chemistry lab.

Skills:

• 1-3 years bench experience (including undergraduate/graduate research experience)
• HPLC a plus

Candidates must live local and be a US Citizen or Green Card Holder

Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in science, engineering and green technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise,advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.

www.cwsciences.com

Participate in study specific meetings, assist with cost tracking, assemble all necessary documentation for clinical trials, assist with regulatory and ethical regulations, and assemble/maintenance and archiving of the TMF.

Requirements:

• BS/MS in Biology or related field with 2+ years experience in a clinical setting.
• Must have experience assembling, maintaining, and archiving TMFs
• Must have experience with contract AND budget negotiation

Candidates must live local and be a US Citizen or Green Card Holder

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc.
www.cwsciences.com

Responsibilities:

• Support users with routine maintenance of the Clinical Trials Management System - ClinTrack.
• Support final users in entering data into ClinTrack by running training, refresher training and overcoming issues.
• Set up and maintain master data in ClinTrack, as requested by users
• Ensure a correct and timely data entry / update process for ClinTrack and perform updates also on behalf of the data owner
• Provide orientation and guidance on ClinTrack processes, present in SOPs, WIs and related documents
• Support MySites Training and first line support. Provide guidance on MySites accounts
• Provide support to users in running the ClinTrack Reports

Requirements:

Education: Bachelor's degree Skills 2+ years performing listed duties within a ClinTrack system

Candidates must live local and be a US Citizen or Green Card Holder Email resume to: jobs@cwsciences.com

Commonwealth Sciences is a professional recruiting firm specializing in Science, Engineering and Green Technologies. We unite industry professionals with exciting career opportunities by leveraging our technical expertise, advanced recruiting tools and years of staffing experience. CWS works with a variety of disciplines and levels from Research Associates to Scientists, Engineers, Managers and Directors. Our clients value the basic integrity, customer service and industry expertise that defines our organization.

Commonwealth Sciences, Inc. www.cwsciences.com