Careers

1.      Medical Director Diabetes &/or Cardiovascular

2.      Director, Neuroscience

3.      Medical Communications & Associate Medical Director

4.      VP, Regulatory Affairs

5.      Senior Regulatory Affairs

6.      VP, Scientific and Medical

7.      Manager of Clinical Research Compliance

8.      Medical Data Entry

9.      Medical Safety MD

10.  VP, Clinical Oncology

11. Codes and Standards Engineer, Medical Device Compliance

12. Medical Scientist

13. Drug Information Manager

14. Regulatory Compliance Specialist

15. Coding and Compliance Documentation Manager

16. Senior Clinical Research Associate

17. Clinical Research Associate Clinical

18. Sales / CRO Business Development

19. Proposal Writer—CRO/Clinical Research

20. Director of Quality

21. Clinical Data Manager

22. Project Manager/Sr. Project Manager

23. Quality Engineer III

24. Medical Director Diabetes &/or Cardiovascular

25. Director, Neuroscience Medical Communications

26. Associate Medical Director

27. Senior Regulatory Affairs

28. VP, Regulatory Affairs

29. VP, Scientific and Medical

30. Manager of Clinical Research Compliance

31. Medical Safety MD

32. Medical Data Entry

33. Medical Scientist Drug Information

34. Manager Regulatory Compliance

35. Specialist Coding and Compliance

36. Documentation Manager

37. Senior Clinical Research Associate

38. Clinical Research Associate

39. Clinical Sales / CRO Business Development

40. Proposal Writer—CRO/Clinical Research Director of Quality  Clinical Data

41. Manager Project Manager/Sr. Project Manager Quality Engineer III

 

Apply now: HR@gapsos.com

 

 

Medical Director Diabetes &/or Cardiovascular

• PhD, MD, PharmD, DO advanced degree
• At least 2+ years experience in a Medical Education, Medical Communications company or Pharmaceutical setting working directly in the desired therapeutic areas (Diabetes &/or Cardiovascular)
• Understanding of AMA guidelines
• Proposal writing and Document editing abilities/experience
• Strong Scientific Background
• Content Development experience
• Ability to provide independent medical direction
• Strong written and verbal communication and presentation skills.
• Excellent computer software experience
• Familiarity or interest in pharmaceutical marketing
• Ability to work both independent and as a team

Director, Neuroscience

• MD preferred or PhD /PharmD with medical affairs or clinical development experience.
• 5 years pharmaceutical or relevant medical clinical experience.
• Demonstrated track record of clinical and or medical development of
  new or in market products or relevant experience.
• Successfully managing high performance, cross functional teams or complex organizations.
• Strong leadership presence and able to represent GMA in multiple forums both internally and externally.
• Understands alignment and collaboration with Global Marketing GCR regional medical affairs Experience collaborating with senior medical and marketing colleagues strong understanding of product development.

Medical Communications

• A life science or pharmacy degree, or equivalent.
• 1-3 years of relevant experience pharmaceutical industry experience, with experience in medical communications preferred.
• Experience in on-line medical literature and drug information database searching.
• Demonstrated ability to accurately and effectively evaluate medical/scientific literature.
•  Understanding of legal requirements, regulatory issues, codes of practice and guidelines in the provision of Medical Communications services
• Committed to customer focus.
• Computer literacy.
• Excellent written and oral communication skills.
• Strong time management skills.
• Ability to read, analyze and interpret scientific and technical information.
• Good analytical problem solving and decision making skills.
• Ability to work as a member of cross-functional teams.
• Ability to be self-sufficient and resourceful.
• Must be able to assess multiple competing tasks and demands, identify priorities and manage deliverables.
• Must be able to prioritize requests for information and seek direction from supervisor or team members as appropriate.
• Responsible for the selection and evaluation of medical, scientific and technical literature within assigned therapeutic area.
• Responsible for decisions related to on-line searching strategies with input from supervisor and peers as needed.

Associate Medical Director

• Responsible for the development of an IST working plan for appropriate products or therapeutic areas.
•  Responsible for providing medical input into development, execution and interpretation of Phase I, II, III and IV clinical protocols. This includes review of draft IST protocols, reports and manuscripts.
• Oversee clinical registries and evaluate safety issues associated with products and promotional activities in accordance with respected regulatory requirements.
•  Assist in critically evaluating study results in statistical and final reports and ongoing reviews with study investigators, resolving problems arising in the course of clinical investigations and preparing reports to the management and medical community.
•  Responsible for direct interaction with investigators, KOLs and the research community to support company initiatives.
• Responsible for representing at scientific, clinical and business development meetings
• .Direct medical writing activities associated with Medical Affairs to ensure accurate execution of product dossiers, product related slide decks, standard response letters, FAQs as well as corporate abstracts, posters, oral presentation and manuscripts when appropriate.
• Promote effective communication between internal and external groups regarding Medical Affairs initiatives.
• Act as a key member of the ISTRC and MPRC committees
• Serve as medical and technical resource for clinical issues raised by internal and external collaborators, investigators, consultants and contract resources
•  Interact in collaborations with strategic partners
• MD with US licensure or fellowship required
• Expertise in genetic disease and metabolic diseases desired
• 2+ years experience in pharmaceutical or biotech industries is preferred
  Intellectual strength, analytical ability and high professional standards in designing, conducting and evaluating research
• Clinical trial experience and publication experience essential
•  Knowledgeable and current in GCP guidelines in US and Europe
• Be well connected within the medical and scientific community and have a proven successful track record in management
• Outstanding leadership, team, presentation, written and oral skills required
• Collaborative and flexible in personal interactions at all levels of the company
• Ability to work proactively and effectively, with exceptional creative problem solving skills

Senior Regulatory Affairs

• Prepare and obtain clearance of domestic and international 510(k) product submissions to meet regulatory requirements for new products and for existing product renewals and registrations.
• Ensure that all supporting documentation is accurate and in compliance with regulatory requirements for domestic and international regulations.
• Maintain regulatory affairs files such as technical files, device listings, certificates, licenses, etc.
• Participate on and/or provide regulatory support for new product design/project teams.
• Review and recommend changes for labeling and marketing literature for regulatory compliance.
• Communicate/interface with the authorized representatives, authorities, and other regulatory agencies to achieve approval for market release.
• Evaluate the impact of regulatory changes to existing products and recommend strategies to facilitate smooth transition when such changes are required.
• Assist and participate in audits.
• Review engineering change orders.
• Assist with medical device/vigilance reporting requirements.
• Perform and assist with post-market surveillance on an annual basis.
• Serve as a regulatory member on product teams.
• Bachelor's degree required.
• 3+ year’s 510(k) regulatory experience for a medical device or diagnostics company.
• High-level analytical skills and ability to focus on detail.
• Working knowledge of both domestic and international device laws and regulations.
• Computer skills in the following applications: Word, Excel, Databases and the Internet.
• Demonstrated, excellent written and verbal communication skills.
• Experience and expertise in using project management and problem solving techniques.

VP, Regulatory Affairs

• The ideal candidate will have a minimum of 10 to 15 years regulatory affairs industry experience in Class III medical device products, with at least 5 years of management/supervisory experience.
• Experience leading Regulatory Compliance across a division or company a must.
• The desired candidate must possess at least a Bachelors degree from an accredited university/college in a relevant scientific discipline or equivalent combination of education and experience. Preference will be given to candidates possessing an MBA, PhD, MD or PharmD degree.

Vice President, Scientific and Medical

• Responsible for providing all epidemiologic services to the marketing and sales teams in positioning our Periapproval Services program offerings.
• This is a strategic leadership position that will collaborate with other key scientific leaders, both internal and external, in order to assess the strategies and opportunities for assisting clients in the successful execution of clinical trials.
• Key objectives include creating functional or therapeutic concentrations that can leverage skills and capabilities to drive a differentiated value for customers. This position will collaborate with medical leadership. Externally, this individual will network with contacts at the senior management level of customers and interact with regulatory agencies (i.e. FDA)
• Provide scientific strategic leadership for Periapproval Services.
• Provide expertise and guidance in the areas of product safety categorization and risk management.
• Present medical/scientific capabilities to potential clients as a participant of the proposal teams.
• Ensure that the scientific directors provide medical/scientific expertise to project teams in protocol development and site selection.
• Participate in training opportunities to advance knowledge of drug development and good clinical practice guidelines.
• Support the company’s visibility and position within the contract research organization environment through publications and presentations at national and international meetings.
• Develop new and enhance existing client/investigator relationships whenever possible.
• Collaborate with Marketing and Operations to set strategy tailored to customer’s needs and expectations.
• Work across the organization to build successful working relationships with business and scientific leaders.
• Provide performance evaluations and career development of direct reports and staff.
• Responsible for the administration and/or delegation of activities of direct reports.
• 8-10 years of experience in pharmaceutical or biological product development either as an investigator, consultant or employee of a pharmaceutical/biotech company or a service provider. Up to four years of clinical practice experience can be used for commercial experience.
• A thorough knowledge of drug development commercialization and the post approval lifecycle.
• An individual that is recognized as a clinical research leader with demonstrated strategic focus and problem solving ability.
• An individual that is high-energy and that has the personality to build teams within the Medical and Scientific Affairs organization as well as the company.
• Ability to manage a high degree of complexity and multiple projects simultaneously.
• Ability to lead and manage a staff located in a multi-office environment.
• Outstanding communication, negotiating, listening, and customer service skills with a focus on satisfying client needs.
• Excellent written and communications skills.
• Knowledge of budgeting, forecasting and fiscal management
• The ideal candidate will possess an M.D. or D.O. with Board Certification in a medical specialty. Postgraduate training in the area of Public Health is a plus.

Manager of Clinical Research Compliance

• Report to the Director, Regulatory Affairs while being responsible for the management of the Office of Research Affairs and Supervision of Office of Research Affairs staff.
• Will manage processing of clinical research protocols and related documents and activities for the Main Line Hospitals Institutional Review Board (MLH IRB) to assure compliance with MLH IRB Policies and Procedures, and other governmental regulations.
• Bachelor’s degree required. Master’s degree preferred. Graduate of a school of nursing or medical practice or equivalent preferred. CIP certification a plus.
• Strong managerial and supervisory skills required.
• Familiarity with and /or experience in managing the implementation of Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) regulations for clinical research compliance preferred.
• Thorough understanding of federal, state, and local guidelines for clinical research compliance, Experience with IRB.
• Strong written and verbal communication skills.
• Detail oriented with ability to prioritize.
• Proficient in the use of the Internet, Microsoft Word, Excel, PowerPoint and database systems.

   Medical Safety MD

• Develop and nurture relationships with external key opinion leaders and consultants in the clinical community.
• Establish strategy, assesses, recommends for support, and manages global involvement in customer-initiated pre-approval (investigator sponsored) and Phase IV clinical studies.
• Establish and maintain understanding of risk tolerance and develops profiles of acceptable studies for funding.
• Establish and maintain Phase IV objectives and accountabilities through interactions with senior level cross-functional management.
• Participate in key engagement priorities with customers, senior management and customers/investigators as needed.
• Develop medically-based standard answers to program, procedure, or product related questions.
• Develop content-driven educational programming.
• Support customer-initiated research, publications and presentations.
• Support marketing and clinical in ways that positively impact product lifecycle
• Coach, mentor, and teach others in the appropriate application of laws and standards in the areas of clinical trial design, compliance, and ethical conduct of Phase IV programs.
• Influence global consistency of Medical Affairs related activities.
• Ensure that all medical affairs are handled in an exemplary legal and ethical manner, ensuring the safety and efficacy of the company's products
• Medical Safety experience

Vice President, Clinical Oncology

• Providing drug development expertise to support strategic business activities
• Providing guidance for clinical development plans in compliance with applicable regulatory, medical and ethics guidelines.
• Interacting with investigative sites on issues of patient safety and eligibility.
• Directing preparation or provides medical review of documents for submission to regulatory authorities.
• Providing support to clinical operations and clinical support of CRAs on assigned projects.
• Serving as Scientific Advisor and provides guidance to Project Managers on medical aspects of projects
• Providing executive leadership for study teams when necessary to manage project related challenges and to achieve exemplary customer service.
• Ensure the improvement of the execution of clinical project processes.
• Providing expert consultation to the group and supports the due diligence research of select compounds and/or companies as requested.
• Taking ownership for strategic initiatives within assigned unit of accountability including development of measures for success.
• Proven track record of innovation (out of the box thinking) in Clinical design and execution
• Experience and knowledge of global development requirements in Oncology (US, Europe, Japan, China, Pacific Rim)
• In depth knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
• Strong leadership skills and effective presentation skills
• Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint
• Strong written and verbal communication skills including good command of English
• Excellent organizational and problem solving skills
• Effective time management skills and ability to manage competing priorities
• Ability to establish and maintain effective working relationships with coworkers, managers and clients
• Medical degree and board certification in oncology sub-specialization
• Membership in a National Medical Association and Clinical Oncology Association
• 10 yrs of experience working on clinical trials with 5 years experience in a strategic leadership capacity
• 10 years experience dealing with external clients
• Occasional TC conferencing at “off business” hours resulting from meetings being held in US and Japan.

Advanced Codes and Standards Engineer, Medical Device Compliance

• In this role you will work with New Product Development Teams to realize compliant products based on national and international codes. This position also has the responsibility for design change surveillance and general technical file maintenance for the life of the products.
• Resolve compliance issues by working with various engineering disciplines such as electrical, mechanical, and software.
• Define compliance strategies to certify and list products.
  Provide technical review of product to ensure alignment with national and international codes.
• Maintain and sustain the product technical files for the production life of the products.
• Assist product development teams in applying and understanding design standards and codes.
• Submit required compliance reports to safety agencies and review 3rd party technical files and documentation.
• Review user documentation to ensure that required warnings, labels and symbols are properly documented as required by standards.
• Maintain necessary technical and certification files for agency review and approval, as needed.
• May have some supervisory responsibilities as required based on projects.
• BS Degree in Electrical Engineer or equivalent experience
• Minimum of 5 years experience in Compliance Engineering equivalent in working with Notified Bodies and standards.
• Minimum of 5 years experience in the medical device industry.
• Knowledge of IEC based safety standards, preferred: IEC/EN / UL 60601-1, IEC 60601-1-1, IEC60601-1-4 and EN 60601-2-38.
• Self-motivated with high performance standards.
• Excellent written and oral communication skills.
• Previous Design Compliance experience preferred

Medical Data Entry

• The positions require 2+ yrs of medical claims examining exp.
• Candidate will be a detail-oriented team player and will process all types of medical claims in a fast-paced office.
• Must possess good knowledge of HMO guidelines, CMS and DMHC compliance regulations.
• Must be familiar with application of CPTguidelines, Medicare Rules and Regulations, CCI bundling and use of DOFR for liability.
• Medical Billers
  Medical Collections
  Medical Data Entry
• The positions require 2+ yrs of medical billing/medical collections exp in a multi-specialty environment. WC exp helpful.
• Knowledge of all facets of billing including demonstrated exp in the use of ICD-9 and CPT codes.
• Data entry position requires knowledge of medical/diagnosis terminology and good keying skills.

Medical Scientist

• The qualified candidate will have a minimum of BA/BS, with an advanced degree at the graduate level in life science preferred (e.g., Pharm.D., M.S., M.P.H., Ph.D., M.D.)

• At least 2 years of work experience, preferably in related areas (scientific Liaison, medical communication, CRA, clinical research, academic position in health science research).

• Vascular disease experience is preferred.

• Position will require up to 70% domestic and international travel and excellent written and oral communication skills.
• Comfort with utilization of computer, company applications, and remote technology and the ability to demonstrate high organizational skills and sound judgment in all functions are required.

Drug Information Manager

• Reviews promotional and sales training documents for scientific accuracy and regulatory compliance of information and presentation as needed.
• Works with co-promotional partners when necessary to reach consensus on product information to be provided to customer base, including healthcare professionals and managed care markets.
• Interacts with healthcare professionals and consumers to respond to informational requests and referrals related to marketed and investigational products, and provides documentation as requested and appropriate to targeted audiences.
• Serves as a medical and scientific training resource to Marketing\Sales and Drug Safety, providing overviews of medical information, background information and clinical use profiles on products within targeted therapeutic areas, and creates responses for internal and customer-related issues.
• Interacts with Drug Safety, Clinical and Regulatory (R & D) personnel to review current international literature databases of interest, provide information, reviews, and summaries, and maintains files of current biomedical literature as it pertains to internationally marketed and investigational products as part of a company-wide resource center.
• Attends external meetings and seminars to broaden industry experience and benchmark standard practices.
• Manages Product Services Specialists; mentors PharmD students, Resident, and vendor personnel as needed.
• PhD or PharmD required.
• 4+ year’s pharmaceutical/clinical experience.
• Knowledge of U.S. regulatory standards related to pharmaceutical manufacturers' communications and dissemination of medical information.
• Knowledge of clinical trial and drug approval process, clinical application of drug products.
• Experience in oncology and critical care medicine.
• Knowledge of international guidelines for dissemination of medical information and international labeling conventions.
• Leadership and management training.
• Experience in managed care or formulary review and/or Clinical Writing, Presentation skills, online and Internet database search skills.
• Experience in vendor management.

Regulatory Compliance Specialist

• Provides expertise in monitoring and reporting of product complaints, serving as primary contact.
• Addresses and expedites product complaint information under the company's complaint policy and procedures, and ensures compliance with federal regulations.
• Follow departmental processes and systems to ensure regulatory compliance.
•  Provide solutions to a variety of technical and systematic problems of basic scope and complexity.
•  Monitors complaint activity and provides suggestions to appropriate company management to modify existing manufacturing or packaging process based upon pattern and related analyses.
• Provides technical support to help optimize complaint processing systems.
•  Maintains and monitors systems to ensure that all product complaint investigations received are appropriately investigated and concluded per the company's complaint handling procedure.
• Two or four-year degree, Typically in the engineering or sciences, and 0-1 years medical device-related experience
• Proficient with the use of computers and MS Office including programs for data management (e.g. Excel, database programs)
• Must possess strong writing and communication skills, problem-solving abilities, and excellent organizational skills for tracking product complaints/events.
• Strong knowledge of medical terminology and cardiac anatomy
• Should be detail and team-oriented and be able to function independently in a busy department while working with cross-functional teams

Coding and Compliance Documentation Manager

• RHIT, RHIA, or CCS
• 5+ years of experience in coding in an acute care facility, 3+ years of Management
• 5-10 years of relevant experience in Compliance Documentation (CDIP)
• Extensive working knowledge of MSDRG's and POA's, ICD-10 knowledge is highly preferred
• Revenue Cycle focus
• Strong mentoring and training experience

Senior Clinical Research Associate

I       Pre-Study Period

A.      Tasks

• Identify potential investigators for studies to be initiated.
• Participate in pre-study and study initiation visits.
• Ensure completeness and compile regulatory documents (e.g. IRB approval, informed consent, lab certification etc.).
• Coordinate study material (e.g. CRFs Clinical Trial Material {CTM}) shipment and receipt by study site.
• Report findings at pre-study and initiation visits in site visit report.

B.    Knowledge and Skill Required to Complete Tasks

• Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
• Understanding of corresponding standard operating procedures.
• Ability to understand and coordinate multiple study protocols.
• Oral and written communication skills.
• Planning and organizational skills.
• Understanding of clinical research principles and process.
• Data collection and editing skills.

 II     Active Study Period
 A.    Monitoring Tasks

• Assess protocol adherence at study site.
• Ensure proper storage of CTM and documentation of CTM accountability.
• Check CRFs for accuracy and completeness.
• Verify adequate source documentation.
• Transmit CRFs to appropriate person/persons.

 B.    Activities outside Monitoring Visits

• Frequent and complete communications with sponsoring company.
• Frequent and complete communications with study sites.
• Maintain documentation of telephone communications.
• Generate written correspondence with study sites.
• Prepare reports of monitoring visits.

 C.    Knowledge and Skill Required to Complete Tasks

• Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
• Understanding of corresponding standard operating procedures.
• Ability to understand and coordinate multiple study protocols.
• Knowledge of therapeutic areas.
• Oral and written communication skills.
• Planning and organizational skills.
• Interpersonal skills.
• Problem solving/decision making skills.
• Attention to details.
• Understanding of clinical research principles and process, data collection and editing skills.

III    Study Termination Period
A.    Study Termination Visit and Tasks

• Complete CRF review, retrieve CRFs and transmit to appropriate person/persons.
• Resolve data management queries.
• Ensure compliance with regulatory requirements for CTM accountability.
• Ensure compliance with regulatory requirements for study files.
• Complete final study termination visit report.
• Knowledge and Skill Required to Complete Tasks
  • Working knowledge of FDA regulations, ICH Guidelines and HIPAA.
  • Understanding of corresponding standard operating procedures.
  • Ability to understand and coordinate multiple study protocols.
  • Oral and written communication skills.
  • Planning and organizational skills.
  • Understanding of clinical research principles and process.
  • Data collection and editing skills.

OTHER SKILLS AND ABILITIES:

REQUIREMENTS:

• Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate  OR
• Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
• Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a pharmaceutical or biotechnology company

Clinical Research Associate

• The clinical research associate monitors activities at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs, and study protocols. 
• Review regulatory documents as required and prepare site visit reports. 
• Responsible for multiple projects and must work both independently and in a team environment. 
• May participate in the study development and start-up process including reviewing protocols, designing and/or reviewing CRFs, preparing Informed Consent forms, developing study documents, organizing and presenting at investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training. 
• May participate in clinical training programs and maintain awareness of developments in the field of clinical research as needed.
• Prefer BS/BA.
• 1 year monitoring experience or combination of on-site monitoring and clinical research coordinator experience.
• Customer service orientation.
• Sound knowledge of medical terminology and clinical monitoring process.
• In depth therapeutic and protocol knowledge as provided in company training.
• Ability to perform regionalized travel an average of 65%, depending on project needs.
• Excellent verbal and written communications skills.
• In depth therapeutic and protocol knowledge as provided in company training
• Excellent interpersonal and organizational skills and attention to detail.
•  Computer literacy, proficiency in MS Office.

Clinical Sales / CRO Business Development

• A minimum of a M. S. or Ph. D. in Clinical Pharmacology, Biostatistics, Chemistry, Biochemistry or relevant field.

• Ideal of seven years or more experience in both direct sales and sales management roles.
• Minimum two years of experience of successful selling clinical documentation services on behalf of a CRO to drug innovators (Pharmaceutical, Biopharmaceutical and Biotechnology industries).

• Demonstrated selling track record.
• Advanced understanding of the various selling models.
• Thorough understanding of 21 CFR part 11, GCPs and ICH guidelines.
• Thorough understanding of the entire drug development processes from IND through all phases of clinical drug development.
• Excellent English communication skills, written and oral are required.

Proposal Writer—CRO/Clinical Research

• In association with the Sales Director, the Proposal’s Manager/Writer will be responsible for writing and negotiating business proposals concerning the translation of PRO questionnaires with our clients,
• Prepare project offer analysis.
• Develop client specific presentations and proposals (methodology, costs, deadlines, etc)
• Write detailed specifications and documentation.
• Manage client negotiations to contract acceptance.
• Coordinate and manage operational team briefings.
• Coordinate and attend client meetings.
• Experience in the planning and negotiation of business proposals.
• Ability to analyze the level of difficulty of text to be translated.
• Strong project management experience with proven track record of meeting project deliverables.
• Excellent oral and written communication skills.
• Fluency in more than one language and strong aptitude in linguistics and language translation is preferred.
• Ability to analyze and synthesize data.
• Ability to interact confidently with members of clinical and scientific teams and clients.
• Excellent computer skills (Word, Excel, Internet).
• Self-motivated, resourceful team player with excellent organizational skills, attention to detail, and ability to perform multiple tasks.
• Bachelor’s degree in linguistics or related field, with 3-5 years related experience is a plus

DIRECTOR OF QUALITY

• Will consolidate, manage, and extend our current quality program to ensure GxP compliance.
• Will contribute as a hands-on Director in an individual contributor role.
• Will distill from the imprecise language of government regulations the essence of those often complicated and imprecise rules and lead the company to an understanding of how to choose the right quality approach that will satisfy regulators as well as Wolfe business objectives.
• Will provide the necessary training to Wolfe employees.
• Will conduct quality audits, both in-process and data audits.
• Will coordinate and participate in inspections by client companies and regulatory authorities insuring that Wolfe is properly prepared and that the inspections are well managed and successful.
• Bachelor’s degree in Chemistry, Biochemistry, or related field

• Seven (7) years of experience in a Quality role in a pharmaceutical company, CRO, or similar business
• Three (3) years of experience in a GxP environment
• Two (2) years of experience in a leadership or managerial role in the quality field
• Demonstrated ability to manage multiple quality programs and deliver on time results
• Considerable current expertise in the regulatory world of pharmaceutical companies and CRO’s including in-depth understanding of regulatory requirements in the drug development process
• Is able to properly interpret the regulatory landscape for Wolfe and defend the choices.
• Experience hosting regulatory inspections as well as doing audits
• In-depth knowledge of GxP requirements
• Experience in a training role
• Excellent communications skills including written, oral, presentation and listening skills
• Highly organized with strong project management skills
• Proficiency in Microsoft Word, Outlook, Excel, and PowerPoint.
• Advanced degree in Chemistry, Biochemistry, or related field

• Ten (10) plus years of experience in a Quality role in a pharmaceutical company, CRO, or similar business
• Five (5) plus years of experience in a GxP environment
• Five (5) plus years of experience in a leadership or managerial role in the quality field
• Experience in both large pharmaceutical and small or start-up companies
• Experience as a consultant in a consulting practice focused on quality programs in pharmaceutical companies
• Demonstrated experience as a quality champion
• Demonstrated ability and willingness to be hands-on in the multiple aspects of a successful quality program

• Possesses excellent attention to detail as well as a big picture understanding and appreciation
• Demonstrated ability to work well under pressure and commit to aggressive timelines
• A passion for playing the multiple roles of scientist, guide, trainer, mediator, business person, administrator, and salesperson
• Demonstrated ability as a flexible and effective consensus builder.

Clinical Data Manager

• Responsible for managing data management activities, liaising with CRO’s and interfacing with Clinical Operations on behalf of the Data Management Department to ensure that standards are communicated properly, that timelines are met according to objectives and goals and that data reporting needs are scheduled and addressed and that the quality of data management deliverables are monitored.

• Review CRF design.
• Create CRF Completion Guidelines/Mock CRF’s and coordinate their review and approval
• Review and approve Data Management Plan components, i.e., study summary/data flow diagrams, timelines, critical variables list, etc.
• Review Data Validation Specifications and coordinate input for Biometrics/Data Management Departments to ensure that Statistical Analysis Plan (SAP) requirements will be met
• Specify data review tools to be included in CRO’s data validation process to ensure that safety and SAP requirements are met
• Represent department on clinical trial team, project management and status reporting
• Handle AE/SAE reconciliation

• Bachelor’s Degree in Life Sciences, Pharmacy or Nursing with 5 or more years of experience in drug development and the discipline of data management or an equivalent combination of training and experience.
• Experience in Oracle Clinical data management system and familiarity with SAS required

Project Manager/Sr. Project Manager

• Assist in the management of an active pipeline in preclinical research.
• Work closely with researchers to develop project plans and schedules and will assist in the management of day-to-day functional activities and hand-offs between research groups.
• Candidate will develop into the go-to person for timing and milestone information for early-stage projects within the special therapeutic area.
• Assist project progression successful candidate will facilitate cross-functional product development team meetings.
• The individual will also support the management of research-driven alliances and partnerships and to this end will act as a key interface between research legal and finance groups.
• The individual will also work closely with the corporate project management group to define and implement a project hand-off system for later-stage programs.
• The individual will work with members of non-clinical and regulatory team to manage the writing and editing of regulatory submissions
• demonstrated project management and integrated project planning ski
• Strong analytical skills with a working knowledge of the biological sciences and product development.
• Demonstrated successful experience working on complex cross-functional project teams.
• Computer skills including MS Office Suite and database and project management software.
• Excellent communication (oral and written) and interpersonal skills. Strong organizational and time management skills required.
•  Must be able to work independently on multiple tasks in a fast-paced environment.
• B.S. /B.A. in the Biological Sciences or equivalent work experience are required with a background in cancer research preferred. Advanced degree (MBA MS or PhD) is preferred.
  

Quality Engineer III

• This position requires a minimum educational requirement of a Bachelor's degree, preferably in Life Sciences or Engineering
• 4 - 6 years in related work experience.
• Candidate must have excellent analytical, prioritization, communication, and strong leadership skills,
• Candidate has the ability to work independently with minimal supervision.
• Candidates need knowledge of the principles and practices of quality assurance in the cosmetic, OTC, pharmaceutical or medical device industries.
• Candidates with knowledge of cGMP requirements and current FDA enforcement regulations are.
• Strong computer skills including MS Excel, MS Word, and PowerPoint are required for this position. LIMS software experience is a plus.

• Benchmark Analysis
• Clinical Affairs
• Due-Diligence
• Legal
• Marketing
• Medical Affairs
• Mergers and Acquisitions
• Regulatory
• Safety
• Technical Augmentation
• Technology Transfer