Job Title

Position Description

• Role Holder will have responsibility to design and implement innovative Health Economic and/or Outcomes Research activities and produce scientific evidence to optimize price and value proposition.  The role holder will assist communication efforts of value proposition and evidence to achieve maximal commercial success of products throughout their life cycle.  The role holder will have in-depth, specialist knowledge of Health Economics and Outcomes Research (HE&OR) and its application to pharmaceutical development throughout development process.
  

Position Responsibilities

• Evaluate and analyze information and generate high quality health economics and/or outcomes research input to the product profile and claims and value demonstration plan.
• Proactively and independently contribute to research planning process and resolution of complex issues, which may impact market access decisions and evidence for product.
• Member of the Value Demonstration Work Stream if applicable.
• Interact with cross-functional team members at a project level.
• Supports Clinical Project Team (CPT).
• Manage HE&OR activities as designated by HE&OR team leader.
• Assist study team personnel and associates in patient reported outcome instrument development and/or administration and or model development.
• Identifies external HE&OR data sources and literature references.
• Prepares proposal requests for Health Economic and Outcomes Research work projects and manages selection process. 
• Budgeting accountability for sub-projects within the health economic project team. 
• Prepares technical presentations.
• Assists in writing preparations, references, and development of  reimbursement/formulary documents.
• Prepares HE&OR data as background materials and registration pack for discussion with regulatory authorities. 
• Advances knowledge about health economics and outcomes research and the impact of pharmaceutical product development.
• Advance expertise in health economics and outcomes research through presentations, publications.
• Adaptation of global core value documents, communication materials, publications for use with US decision makers and purchasers.
   

Position Requirements

• Bachelors degree in clinical, biological, or social sciences.
• Masters degree in relevant field (outcomes research, health services research, epidemiology, health economics, health policy or related fields)
• Doctoral degree in relevant field preferred.
• Ten years of relevant experience, five of the years in the pharmaceutical/medical industry.
• Two years previous project experience in Health Economics and/or Outcomes Research.
• Previous project management or personnel management preferred.
• In-depth specialist knowledge of Health Economics and/or Outcomes Research and its application to pharmaceutical development at an international level.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages. 
• Knowledge of international healthcare systems and their changing needs for health economic and patient-reported outcomes information. 
• Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
• Proactive application of therapeutic area and disease treatment knowledge.
• Able to implement projects including key stakeholders with high degree of autonomy.
• Excellent written and verbal communication skills.
• Requires high level of interactive communication including challenges to conceptual thinking as necessary. 
• Communicate  project plans to commercial stakeholders.
• Proven teamwork and collaboration skills.
• Well-developed cultural sensitivity.
• Effectively represents the company externally to key
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Manager/Sr. Manager Regulatory Affairs

Position Description

• 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.
• 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.  

Position Responsibilities

• 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 Regulatory business function on technology teams.
• Manage compliance-related submissions and activities.

Position Requirements

• 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. The Submission Manager will utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.
• Experience in or direct knowledge of 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.
• Must be detail-oriented, flexible, and able to function in a multi-tasked environment with time constraints. Excellent communication, organizational, and interpersonal skills are required.
• Knowledge of document management and electronic publishing systems (Documentum, MS Office applications, Adobe Acrobat, MS Project, SAS Viewer, SAS JMP) is a strong plus. Strong general technology skills and ability are required.

Job Title

• Sr. Manager/Associate Director, Regulatory Submission Management

Position Description

• The Sr. Manager will be an integral member of the Global Regulatory Dossier Management Group. The Submission Manager will have overall responsibility for management of complex regulatory submissions, leading cross-functional submission teams for new drug applications (NDAs and MAAs) and investigational applications (INDs and CTAs).  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, managing the cross-functional submission review process and reviewing submission content for completeness and adherence to regulations and regulatory guidance.

Position Responsibilities

• As leader of cross-functional submission teams, 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.
• 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.

Position Requirements

• Minimum of 7 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. The Submission Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.
• 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.  Science degree or background strongly desired.

Job Title

• CMC Manager

Position Description

• This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs.
• This person will serve as the regulatory CMC representative on relevant project teams.

Position Responsibilities

• Develop global CMC regulatory strategy for development products.
• Direct management of assigned development programs.
• Drive all CMC submission activities (IND, CTA, NDA, BLA) and health authority interactions (meeting requests and briefing documents).
• Represent Regulatory Affairs at various project team and working group meetings.
• Assess and communicate CMC regulatory requirements to ensure all development activities are in compliance with applicable regulations and guidelines.
• Expected to develop and manage project timelines as well as have the ability to multi-task.
• Monitor changes to development plans and provide regulatory guidance to teams to bridge changes into the clinic.
• Contribute to the development of comparability protocols, validation protocols, and stability protocols.
• Ensure the quality and content of all submissions to health authorities.
• Liaise with partnering companies to ensure regulatory alliance.

Position Requirements

• Position requires a minimum 4-year degree in Chemistry, Biochemistry, Molecular Biology, Biology or related field; advanced degree helpful.
• Must have a minimum of 6 years experience in Regulatory Affairs or equivalent experience within the pharmaceutical industry.
• Must demonstrate a solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU, Canada, and ROW experience highly desirable.
• Previous experience in leading submission teams for marketing application and/or clinical trial applications and direct experience in interacting with regulatory authorities is also required.
• Candidates must be able demonstrate strong project management, problem-solving, negotiating, interpersonal and communication skills (both written and verbal)

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Regulatory Associate

• Provides project management support for the Mature Product & Geographic Optimization team in the US and ex-US

• Writes complex reports in the context of divestiture management activities.
• Supports the US Liaison activities by coordinating regulatory projects as assigned, with supervision.
• Helps with the preparation of administrative files for Health Authority submissions.
• Supports the team in database searches (PRISM, eSub, IRIS) and literature searches (Cybrary, eJournals) as needed.
• Assists in the development and revisions of department process documents, including divestitures, deletions, onboarding, training checklists and materials.
• Manages metric reporting on regulatory and geographic optimization activities.
• Works independently given the appropriate levels of supervision.
• Demonstrates initiative and responsibility, excellent judgment, and pays attention to details.
• Ability to handle confidential information with discretion. Demonstrates high degree of professionalism, tact, and judgment.
• Ability to handle multiple tasks, set priorities and meet deadlines. Show flexibility and open-mindedness, ability to adapt to a rapidly changing environment.
• Ability to navigate and obtain information through internal/external resources.

• Excellent verbal and written communication skills, including complex Report writing skills
• Strong interpersonal skills with ability to deal with various levels of management and different cultures
• Consistent follow-up on projects
• Problem-solving skills
• Understanding of pharmaceutical development processes, of regulatory processes and Health Authority agencies

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Regulatory Assistant

Position Description

• This person will be responsible for checking records in the electronic library, indexing the paper library and help out with the packaging the submission.
• The person will also be responsible for categorizing, reconciliation, and scanning of Regulatory Affairs legacy documents. 
  

Position Requirements

• Proficient in using - Microsoft Office, Adobe Acrobat Professional, Scanners and Printers.
• Education required is an AA.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

• Clinical Submission Specialist

Position Description

• Publishing of clinical documents/submissions.

Position Requirements

• Strong Document Management skills

• eCTD experience.

• Documentum knowledge.

• Experience with publishing (bookmarking and linking documents) Clinical documents/submissions.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Job Title

Position Description

• Role Holder will have responsibility to design and implement innovative Health Economic and/or Outcomes Research activities and produce scientific evidence to optimize price and value proposition.  The role holder will assist communication efforts of value proposition and evidence to achieve maximal commercial success of products throughout their life cycle.  The role holder will have in-depth, specialist knowledge of Health Economics and Outcomes Research (HE&OR) and its application to pharmaceutical development throughout development process.
  

Position Responsibilities

• Evaluate and analyze information and generate high quality health economics and/or outcomes research input to the product profile and claims and value demonstration plan.
• Proactively and independently contribute to research planning process and resolution of complex issues, which may impact market access decisions and evidence for product.
• Member of the Value Demonstration Work Stream if applicable.
• Interact with cross-functional team members at a project level.
• Supports Clinical Project Team (CPT).
• Manage HE&OR activities as designated by HE&OR team leader.
• Assist study team personnel and associates in patient reported outcome instrument development and/or administration and or model development.
• Identifies external HE&OR data sources and literature references.
• Prepares proposal requests for Health Economic and Outcomes Research work projects and manages selection process. 
• Budgeting accountability for sub-projects within the health economic project team. 
• Prepares technical presentations.
• Assists in writing preparations, references, and development of  reimbursement/formulary documents.
• Prepares HE&OR data as background materials and registration pack for discussion with regulatory authorities. 
• Advances knowledge about health economics and outcomes research and the impact of pharmaceutical product development.
• Advance expertise in health economics and outcomes research through presentations, publications.
• Adaptation of global core value documents, communication materials, publications for use with US decision makers and purchasers.
   

Position Requirements

Education:

• Bachelors degree in clinical, biological, or social sciences.
• Masters degree in relevant field (outcomes research, health services research, epidemiology, health economics, health policy or related fields)
• Doctoral degree in relevant field preferred.

Experience:

• Ten years of relevant experience, five of the years in the pharmaceutical/medical industry.
• Two years previous project experience in Health Economics and/or Outcomes Research.
• Previous project management or personnel management preferred.

Skills:

• In-depth specialist knowledge of Health Economics and/or Outcomes Research and its application to pharmaceutical development at an international level.
• Comprehensive understanding of the pharmaceutical industry and regulatory requirements from a global perspective and product development processes at all life cycle stages. 
• Knowledge of international healthcare systems and their changing needs for health economic and patient-reported outcomes information. 
• Strong knowledge of legal and regulatory environment influencing clinical development plans, labeling and promotional claims.
• Proactive application of therapeutic area and disease treatment knowledge.
• Able to implement projects including key stakeholders with high degree of autonomy.
• Excellent written and verbal communication skills.
• Requires high level of interactive communication including challenges to conceptual thinking as necessary. 
• Communicate  project plans to commercial stakeholders.
• Proven teamwork and collaboration skills.
• Well-developed cultural sensitivity.
• Effectively represents the company externally to key
  

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

• Submissions Coordinator
  

• Responsible for filing necessary applications and handling all government interactions pertaining to the regulation and certification process for a plant or other facility. 
• Developing procedures to ensure regulatory compliance. 
• Prepares reports for top management detailing projects that may impact the organization's regulation status. 
• May represent the organization before federal or state legislations. 
• Familiar with a variety of the field's concepts, practices, and procedures. 
• Relies on extensive experience and judgment to plan and accomplish goals. 
• Performs a variety of tasks. 
• May lead and direct the work of others.

• Creativity 
• Latitude is expected. 
• Basic computer skills, including MS Office proficiency 

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

QC Reviewer / Auditor

Purpose of Position:

·          The primary role is to provide support to the Regulatory Affairs Operations group in the area of Quality Control (QC)

·          Responsibility for accurate electronic Quality Control (QC) review of regulatory documents and submissions

·          Processing documents electronically, auditing tasks, tracking and documentation activities as well as general support tasks, as needed

·          Essential Job Responsibilities:

·          Perform accurate electronic QC review of documents and submissions which are destined for submission to Regulatory Authorities

·          Responsible for completing clear and concise QC documentation and ensuring prompt and complete reconciliation of comments

·          Assures that review of documents and submissions are in compliance with Astellas Pharma US, Inc. approved processes and procedures

·          Provides the support necessary to track and maintain QC documentation as required by current standards

·          Communicates and works closely with Regulatory Affairs Operations group to identify workload priorities and ensure timelines are met

·          Provides support to Regulatory Affairs Operations group as assigned (e.g. process documents electronically, auditing electronic files, file maintenance, etc.)

·          Assists with importing and exporting documentation from Astellas document management systems as needed

Required Qualifications:

·          Technical degree or equivalent experience required

·          Minimum two years experience in pharmaceutical industry or in a QA/QC environment

·          Working knowledge of Adobe and Documentum is required

·          Strong interpersonal, written and verbal communication skills

·          Excellent computer skills in Microsoft Office and database tracking systems required

·          Must be detail oriented and have excellent quality of work

·          The ability to support several projects at the same time while maintaining a high level of attention to detail and quality

·          Experience in area of eCTD, eNDA, including electronic initiatives introduced by FDA is preferred

·          Excellent writing skills with an emphasis on detail

·          Strong problem solving and organizational skills

·          Ability to communicate effectively and to foster positive working relationships with co-workers

·          Ability to be flexible in work hours in order to accommodate tight timelines as well as succeed in ensuring company objectives are met

·          Familiarity with scientific/medical terminology and regulatory documentation desired

Job Title

• Regulatory Affairs Associate
  

Position Description

• Primary Regulatory support for Biosurgery Medical Device products. 
• The manager will be responsible for defining regulatory strategies, regulatory plans and submissions in support of new and existing marketing authorizations.
  

Position Responsibilities

• Develop and execute regulatory strategies, regulatory plans and submissions for projects including new products and maintenance of licenses/authorizations for existing marketing authorizations 
• Designated contact with FDA and liaison with project team for communication and negotiation in support of submission activity 
• Represent or lead the RA function on assigned cross-functional project teams 
• Monitor applicable regulatory requirements; assure compliance with Baxter and external standards 
• Establish appropriate communication within RA and other functions primarily at project level 
• Perform gap analysis and propose solutions 
• Develop and document sound regulatory decisions and justifications 
• Ensure project teams and business objectives and deliverables are aligned with regulatory strategy 
• May provide direct supervision of individuals 
• May review promotional material or SOP’s for compliance with local and global regulations
• Sound basis of Regulatory knowledge 
• Experience with writing and managing submission activities for IDE, 510(k), and PMA submissions 
• Ability to manage complex projects and timelines in a matrix team projects and timelines in a matrix team environment 
• Strong oral and written communication and presentation skills 
• Demonstrated interpersonal skills including strong negotiation skills 
• Ability to independently identify compliance risks and escalate when necessary 
• Ability to lead and coach others
   
  

Position Requirements

• Bachelor’s degree in related scientific discipline with a minimum of 5 years regulatory experience in RA or related field, including managing people or projects.  
• Experience with IDE and Class III PMA submissions required.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance

Delta Pharma is a national leader in the staffing of professionals in the Pharmaceutical, Biotech, and Medical Device industries. Managing the professional staffing needs of leading Pharma companies nationwide, we take pride in bringing Great People and Great Opportunities together.

Job Title

• 
   Manager, Regulatory Affairs DMG
  

Position Description

• The Dossier Manager will be an integral member of the Global Regulatory Dossier Management Group. 
• On a daily basis, the Dossier Manager will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines and projects, overseeing publication activities, and utilizing a wide array of document management, authoring, and publishing tools. 
• The Dossier Manager will also utilize the Common Technical Document (CTD) and the eCTD, and all processes surrounding this capability.
• Working closely with the Regulatory Leads, the Dossier Manager will have an opportunity to develop a broad base of skills in both Regulatory Affairs and submission management.

Position Responsibilities

• 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 establishing electronic submission capability at Millennium, focusing on implementing the eCTD and representing Regulatory business function on technology teams.
• Manage compliance-related submissions and activities.

Position Requirements

• Minimum of 4 years of experience within the pharmaceutical industry and strong project management and/or submission management experience is required. 
• Skill in using desktop applications and proficiency in computer systems and procedures is required.
• Experience in preparing regulatory submissions (e.g., investigator documentation, protocol amendments, etc.) is highly desired
• 4 years Regulatory Affairs or pharmaceutical experience is required
• Experience in a Regulatory Submissions organization along with a working knowledge of drug development process is strongly desired.

Benefits

• Blue Cross/Blue Shield Medical and Vision
• Delta Dental
• 401K with Company Match
• Holiday and Vacation Pay
• Relocation Assistance