Director Biologics Manufacturing - BioPharma Company / Syracuse, NY
Physician Consultant Opportunity - Clinical Development - BioPharma Company / New Jersey
Senior Medical Director - Medical Affairs, Medical Information - BioPharma Company / New Jersey
Physician, Biotech - Immunology/Oncology/Rheumatology, Clinical Development - Biotech Company / Northern New Jersey
Associate Director - Regulatory CMC, Biologics - European Biotechnology Company / Princeton, NJ
Medical Director Laboratory Medicine, Medical Device Minnesota - Medical Device Company / Minnesota
Manager Regulatory Affairs CMC Strategy - Biotech / New Jersey
Director/Senior Director - Clinical Research - Biotech Company / San Diego, CA
Gastroenterologist - Pediatrics - Pediatrics Practice / South Florida
Senior Medical Director, Medical Research Therapeutic Area Head Hypertension - Prominent Pharmaceutical Company / New Jersey
Vice President Medical Affairs, Oncology - Prominent Biotech / New Jersey
Director/Sr. Director - Regulatory, CMC - Biotech / New Jersey
Manager/Senior Manager - Regulatory, CMC - Biotechnology Company / New Jersey
Medical Director/Senior Director, Safety/Regulatory - Biotechnology Company / New Jersey
Lead DCS (distributed control system) Engineer - Power Plant / Tampa, FL
Electrophysiologist - Comprehensive Cardiology/Cardiovascular Surg Pract / Indiana
Cardiologist - Clinical Research Phase II and III - Global Pharmaceutical Company / New Jersey
Director of Regulatory Affairs - Investigational Products - Biopharmaceutical Company / New Jersey
Associate Director/ Director, M.D. - Biopharmaceutical / New Jersey
Salary: $150K - $190K
The Biologics Manufacturing operation produces clinical, commercial and launch biologics drug substance at its 5000L scale manufacturing facility (mammalian cell process). The Director, Biologics Manufacturing is responsible for all components of the manufacturing operations organization, which include: Cell Culture and Purification. Drives resources to address priorities, meet production schedules, maximize productivity, reduce costs, and increase efficiencies through continuous improvement strategies. Develops and leads a high performance management team responsible for commercial manufacturing, directs the recruitment and development of manufacturing staff. Invests in the development of current and future leadership through assignment of development opportunities, coaching, mentoring, and effective administration of rewards and recognition. Establishes and communicates business objectives for manufacturing, consistent with company biologics strategy. Establishes and communicates high performance standards, defines clear accountability, and leads by adopting continuous improvement strategies to reduce operational variances and reduce cycle time. Sets high standards for compliance to meet and exceed regulatory agency requirements related to biologics manufacture and assure compliance with directives including safety, training, cGMP, quality systems documentation, change control, operational variance, and failure investigation. Develops annual operating budget/staffing levels and manages operation to achieve the financial objectives. Participates actively on the site Senior Leadership Team to establish site mission, annual goals and desired culture while undertaking supportive actions which build commitment to these values, objectives and sustained site-wide teamwork.
A Ph.D. or M.S. in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline. A minimum of 8-15 years of successful managerial experience in cGMP biologics manufacturing with a documented history of technical accomplishments. An in depth knowledge of regulatory requirements for filing biologics in the US and Europe. Knowledge related to mammalian cell bank, cell culture and purification manufacturing as well as in depth knowledge of validation for a biologic manufacturing facility. Demonstrated success as a strong team leader who uses past management and supervisory experience to develop departmental staff through effective feedback and coaching. Proficiency in developing and managing departmental budgets. Excellent organizational skills and the ability to successfully manage multiple technical projects and priorities, excellent analytical and strategic thinking skills and experiences with Lean Six Sigma tools. Direct experience with supporting 24/7 manufacturing operations is preferred.
This position provides clinical and scientific input to clinical and project teams. Key responsibilities include the design of clinical drug development programs, protocol development, medical oversight during trial conduct, data interpretation, clinical study report writing, communication of data to investigators and health authorities. Also acts as subject matter expert for assigned projects/initiatives.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The primary roles and responsibilities of this position include the following:
Represents the clinical function on multidisciplinary project teams. Provides scientific advice and contribute to strategic discussions in relation to the assigned products/brands within the company portfolio.
Provides support in companys initiatives and contributes to strategic discussions as subject matter expert.
Develops clinical development plans in collaboration with relevant line function and work closely with the Director, Clinical Operations and/or Study Managers to validate budget and timelines assumptions.
Develops clinical trial protocols in collaboration with internal and external experts (as needed). Responsible for the internal quality review of the protocols and timely submission and presentation to the Protocol Review Committee.
Works closely with the Director, Clinical Operations, Study Managers and Clinical Team on clinical trials for assigned products and provide input on the informed consent form, and other trial-related documents such as Case Report Forms (CRFs), other data collection tools, Statistical Analysis Plan (SAP), and Data Management Plan (DMP).
Works in close collaboration with the statistician and the study manager to establish Data Monitoring Committees as needed
Provides input and review of scope of work for central lab, central ECG and other vendors.
Gives input in site selection. Contributes to investigator meeting presentations and site qualification and/or initiation visits (as needed). Contributes to medical responses to trial-related questions from IECs/IRBs.
Provides disease/compound/trial specific training to Monitors and Study Managers.
Develops trial-related Safety Management Plan (SMP) in collaboration with the Pharmacovigilance group. Assists in the determination whether new safety information requires an amendment to the clinical trial protocol, ICF and/or IB. Contributes to the development of protocol amendments.
Participates in the review, synthesis, analysis and interpretation of clinical data. Contributes to presentation of trial results as needed. Leads the creation and review of clinical study re-ports.
Assists in the creation and review of Investigator Brochures. Interacts with clinicians/investigators at investigator meetings, congresses etc. Assists in the creation and review of regulatory/submission documents (e.g. clinical summaries, clinical overviews, ASR, IND update, DSUR, clinical narratives, Risk Management Plans or REMS).
Contributes to Health Authorities meetings for the assigned products/brands.
EDUCATION AND/OR EXPERIENCE
University degree in pharmacology/pharmacy (DPharm or BPharm), combined with an advanced degree (PhD) in health science. MD degree is preferred. At least 5 years of clinical development experience in a similar or related drug development position (e.g. Medical Affairs, Pharmacovigilance, Pharmacokinetics) experience is required. Therapeutic domain know-ledge (gastroenterology, infectious diseases, or internal medicine) is preferred.
Experience and knowledge of Good Clinical Practices
Excellent knowledge of drug development process
Excellent understanding of pharmaceutical regulations
Ability to work in a multidisciplinary team and to plan work to meet deadlines and effectively handle multiple priorities are required.
Salary: $250K - $K
The Senior Medical Director, Medical Affairs - Global Medical Communications is responsible for providing medical and scientific expertise and oversees all portfolio activities related to Global Medical Information, Medical Communication and Continuing Medical Education; develops and leads the field based medical group; building and maintaining relationships with Key Thought Leaders to increase the organizations visibility as an industry leader.
Essential Duties and Responsibilities: The primary duties and responsibilities of this position include the following. Other duties may be assigned.
Medical content and communication Provides medical content and communication for the company portfolio of marketed products with deep experience in medical communication and life cycle management. Provides scientific/medical support to brand/project planning, and the Life Cycle Management (LCM) team in collaboration with Marketing, other R&D functions, and Specialty Pharmaceutical Commercial Operations. Oversees the dissemination of scientific and medical information related to marketed products. Participates in producing the medical components of INDs, NDAs, FDA and other regulatory communications. Oversees production and revision of AMCP dossiers and supports Managed Care with medical content and presentation to formularies. Develops the strategic plan and provide oversight for medical grants and congresses. Oversees and manages library services and respective contractors. Supports product promotional campaigns to ensure scientific/medical validity, including appropriate messaging of product benefit and warnings. Will develop the education / communication outreach needed for marketed and launch products including advisory boards and speaker programs. Manages Continuing Medical Education programs to ensure educational programs that are accredited and of high quality and consistent with regulatory compliance requirements. Will lead across the portfolio the companys call center(s) and internal stakeholders education for compliance and a seamless execution. Will oversee the development and/or enhancement of medical SOPs for the medical affairs function. Supports development and execution of response letters and FAQs.
Other Hires, assigns, develops and supervises employees under his/her supervision. Attends work on a regular and predictable basis. Completes assigned tasks in a safe manner and in a constant state of alertness. Upholds company policies, including the Professional Conduct Policy and Prohibition Against Harassment Policy, and the Business Ethics and Conduct Code. Works in a cooperative manner with managers, supervisors, coworkers, customers and the public.
Supervisory Responsibilities: Produces value-added results through effective recruitment, delegation, performance management, training and development of employees in the following positions: Medical Science Liaison/s Senior Manager, Medical Affairs Operations
EDUCATION AND/OR EXPERIENCE University diploma in Medicine (MD) with a minimum of six (6) to eight (8) years pharmaceutical or biotech industry experience in medical communications across a global portfolio of products.
This individual will participate in the design of all clinical trials necessary to verify product utility, safety and efficacy; and ensures that the scientific method is reflected in clinical protocols, data collection, and analysis. This individual will also be involved in the interpretation of findings.
Participates in the planning and coordination of world-wide clinical trials program.
Prepares summaries of clinical data for regulatory submissions.
Monitors progress of clinical trials relative to protocol preparation, recruitment of sites, patient accrual, and reporting, and writes protocols and investigator brochures; Takes corrective action to ensure timely completion.
Prepares manuscripts and scientific papers on the Companys products and clinical findings.
Makes presentations and represents company at various industry or association meetings.
Furnishes information needed for Clinical Research/Operations, in preparation of clinical documents and presentations; and to Regulatory Affairs, in preparation of regulatory documents.
M.D., Board Certification in Oncology, Immunology, Hematology or Rheumatology is desired. Otherwise, Doctorate (Ph.D.) degree or equivalent; or more than 10 years related experience and/or training; or equivalent combination of education and experience
Strong analytic and writing skills with publications
Experience in oncology and autoimmune diseases
Biotechnology and/or pharmaceutical industry experience
Experience with Phase I III clinical trials
Knowledge of GCPs and regulatory requirements for clinical trials
Participation in large multi-center and/or global trials, investigational site management, data collection and interpretation, and study protocol compliance
Salary: $125K - $145K
Primary Job Responsibilities:
Develops and implements CMC regulatory strategies for earliest possible approvals of phase 1 through BLA/MAA
filings and post-approval submissions. Ensures timely preparation of organized and scientifically valid submissions.
Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory
Major Duties and Responsibilities:
Oversees Regulatory activities related to drug substance and drug product manufacturing.
Provide regulatory direction on the coordination, preparation & timely submission of CMC sections of NDAs,
BLAs, INDs and related documents and submissions.
Strategic guidance regarding CMC regulatory issues & plans for efficient and competitive product
Represent company with US and International health authorities regarding regulatory CMC issues.
Review of design and proposed changes to regulated processes and /or products to identify regulatory
Organizing, reviewing, and writing CMC sections and summaries as needed from RA perspective.
Interacting with CMC and Quality personnel to provide regulatory guidance and assistance with specifications,
validations, audits, product comparability etc.
Provides additional regulatory support for all RA documents, submissions and functions as needed (may include
preparing and/or reviewing annual reports, Investigator Drug Brochures, Fast Track Applications, drug labeling,
meeting package preparation, etc).
Degree in a scientific discipline, preferably an MS or PhD, with significant expertise with recombinant proteins.
Have 5 or more years experience in CMC regulatory affairs with at least one successful BLA submission.
Experience must include significant involvement and expertise with GMP biotechnology manufacturing
outside of regulatory affairs.
Experience preferably includes involvement with both development phase and marketed biotechnology
products. Experience with US and international (especially EU) manufacturing facilities and regulatory
authorities is desirable.
Experience in multiple phases of regulatory submissions and interactions, ideally including post-approval
experience and direct contact and negotiation experience with the FDA.
Excellent communication skills; team member that can work collaboratively with colleagues across all
Excellent analytical, presentation, and writing skills are required
Salary: $200K - $250K
Reporting to the Group Vice-President, provides medical and clinical input and
related expertise to the Immunoassay and Molecular Diagnostics business group.
The incumbent provides preventive medical direction and scientific input to the
business, advising new product development teams as they develop products that
meet quality standards and the needs of the customers. The incumbent will
participate and advise teams that are managing current business product
performance issues. Is a member of the corporate PCA committee as a
representative of the business unit. Establishes and maintains academic,
biopharma and clinical key opinion leader development partnerships. Through
industry and clinical affiliations, keeps abreast of medical and clinical best
Provide clinical input to Risk Assessments, Failure Mode Effect Analysis
(FMEA), and Health Severity assessments within the risk management process
Lead medical risk assessments with Senior Management. Review and comment on
medical risk assessments for complaints; sign-off on reportability of Medical
Device Reports (MDR)
Review, update and create risk assessment documents and white papers related
to potential product specific malfunctions
Identify and report any quality or compliance concerns and take immediate
corrective action as required
Participate in Company medical advisory boards
Aware of, comply with, and contribute to the Quality Management System,
Quality Management Policy, Quality Goals, and applicable laws and regulations as
they apply to this job type/position.
Communicates research, development and market issues to executive management
Serves as a member of the business unit senior leadership team
Participates in the business units strategic planning process
Participates in relationships with vendors, consultants, contractors and
professional associations as appropriate to keep informed of existing and
evolving industry standards and technologies
Guides business in standard work practices for new product development
Adheres to company policies and procedures
M.D. required with clinical experience
Experience/prior oversight for risk assessment, patient safety & quality
Excellent process knowledge, experience, and skills
Excellent interpersonal, organization, communication and influencing skills
M.D., Ph.D., Board-certified with clinical experience
Experience in planning, conducting and reporting clinical trials (IVD or
pharmaceuticals), laboratory medicine
Demonstrated leadership in the successful management of clinical programs,
including: interpretation, summarization and presentation of scientific data
Demonstrated expertise in technical writing (e.g. published manuscripts in
peer reviewed journals, investigator brochures, and the clinical sections of
PMAs and 510K submissions)
The Manager, CMC Regulatory Affairs will develop global regulatory CMC strategy and submissions for assigned biologic development projects and/or marketed products in conjunction with appropriate RA CMC management. This includes planning, review, coordination and submission of IMPDs, CTAs, INDs, BLAs, etc.
The candidate will proactively provide strategic input and communicate critical topics in a timely manner to interdisciplinary project teams and appropriate management level. Lead cross functional Health Authority response teams for assigned development projects to set objectives for HA meetings, manage interactions and coordinate preparation of HA responses. The candidate must have competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process. Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables.
1.Will have understanding of regulatory CMC requirements, FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
2.Provides regulatory guidance to ensure development activities are compliant with relevant health authority regulations and in line with current global guidance.
3.Communicates global regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
4.Represents Regulatory CMC on interdisciplinary teams and technical project teams to outline submission requirements and negotiate timelines for delivery of regulatory CMC submissions.
5.Assists in preparation of risk analyses and contingency plans for CMC regulatory strategies and dossiers.
6.In conjuction with multi-disciplinary teams, prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
7.Reviews and assesses the regulatory impact of change controls/requests for the manufacture, testing and release of development and marketed products.
8.Assists in the implementation of processes and applications to support regulatory activities
1.Must have 3 5 years of pharmaceutical industry experience including a minimum of 2 years of regulatory or related experience.
2.Demonstrated knowledge of the drug/biologics development process and government regulations/guidelines, including US and international product registration.
3.Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential.
4.BA/BS degree or equivalent experience.
Salary: $200K - $260K
Provides broad scientific and medical support for clinical programs and contributes to the development of clinical research strategy. Plans/oversees studies sponsored by company. Supports other key initiatives including diligence efforts and collaborations with corporate partners. Manages effectively to timelines and budget.
DUTIES & RESPONSIBILITIES:
1. Work with key functions/teams to devise effective and innovative clinical plans, develop study protocols, and identify suitable investigators and consultants for multiple projects.
2. Contribute to the development of clinical research strategy.
3. Manage Phase 1 through 3 clinical studies, ensuring that studies are carried out in accordance with the clinical development plan, timelines, budget, GCPs and company SOPs.
4. Monitor safety of products in clinical trials, and manage the adverse drug event reporting process to assure compliance with GCP requirements.
5. Direct and participate in the preparation of investigational drug brochures, clinical study reports, safety reports, and clinical sections of annual reports, INDs, NDAs/BLAs, SOPs, abstracts, and manuscripts.
6. Organize and conduct investigator meetings and make presentations.
7. Inform management of project team and other activities in a timely way through written and oral reports.
8. Interact with Medical Affairs and Commercial group to ensure a smooth transition from development to commercialization of products.
9. Support Business Development/Medical Affairs diligence activities as necessary.
10. Provide clinical/scientific support to collaborative development projects involving corporate partners.
11. Assist in identification of potential new research or development projects and assess the feasibility of pursuing these projects.
12. Represent company and give presentations at professional/scientific meetings.
1. MD, plus several years of relevant medical / scientific training. This may include training in a relevant medical specialty and/or board in a relevant specialty.
2. Pharmaceutical/Biotech industry clinical research experience: 3+ years for Director and 7+ years for Senior Director
3. Excellent interpersonal skills.
4. Effective communication skills.
5. Effective team participation skills.
Board eligible or board certified in relevant medical specialty ( Internal Medicine, allergy/immunology, gastroenterology, rheumatology)
Publications in the field of related specialty area.
All interested candidates, please contact Steven Karski at 786-347-6300
Please send resumes to email@example.com
Pediatric Gastroenterologist Comprehensive Pediatric Practice, Broward County, Florida
Practice is 100% Pediatrics and is based out of Childrens Hospital. Level 1 trauma Center.
Brand new equipment.
Contribute to building of program.
Shared call 1::2
Compensation is very competitive.
MD in Pediatrics Gastroenterology
We are currently seeking a Sr. Medical Director Medical Research Therapeutic Area Head - Hypertension for our northern NJ location. This position will oversee the strategic and tactical implementation of the commercial Medical Research team responsible for Phase IIIb studies and ultimately Phase IV studies for assigned hypertension products; and oversee appropriate IIS strategies, FMA partnerships, and advisory board strategies. Additionally, you must effectively collaborate with Clinical Research, appropriate brand teams and with co-promote partners to effectively support the commercial scientific efforts for hypertension products.
In this role, you will oversee and assume responsibility for the planning, timely implementation, completion and finalization of assigned studies, IIS strategies and internal customer support as appropriate; oversee the interpretation, publication/ public disclosure and interpretation of scientific data generated by studies; and interact with investigators and members of the medical community to assist in understanding current academic and practice issues to support product strategies and to ensure the appropriateness of studies/projects.
MD or DO; advanced training in cardiovascular medicine is desired. Minimum of 8 years experience in clinical, research or academic medicine; at least 5 years of pharmaceutical industry experience; and experience with cardiovascular products and clinical trial implementations is required in this role. Excellent written and oral communication skills, particularly strong formal presentation skills; strong interpersonal skills commensurate with the need to work closely with outside physicians/ scientists and numerous in-house support groups; knowledge of scientific methods, research design and medical practices and procedures that would be acquired through clinical experience and clinical research studies; good understanding of the current legal and regulatory environment are critical skills in this role. Basic knowledge and appropriate application of biostatistics and experience with cardiovascular products are also required.
Salary: $225K - $275K
Oncology professional with drug development experience in pharmaceutical/biotechnology industry to develop and implement global market support, medical communication/education and research programs of Medical Affairs.
ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Medical Affairs interface with company functional groups including pre-clinical, legal, regulatory and commercial in support of company portfolio products
2. Oversee and manage the global Medical Affairs strategy as it relates to the company pipeline in harmony with company strategic partners, ensuring the needs and requirements of various geographic regions
3. Develop SOPs for global strategic medical communication, education and research programs for company portfolio products
4. Assume responsibility for Phase IV studies and for selected pre-approval pipeline studies.
5. Maintain knowledge of FDA, ICH and GCP guidelines.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE
1. MD degree with background in oncology
2. Minimum of 6 years of pharmaceutical development experience and at least 3 years managing a clinical development or medical affairs group. Hands-on experience with managing more than one major, multi-country, clinical program.
3. Ability to travel up to 25%
4. Expertise in clinical trial design, conduct and interpretation of scientific data.
5. Strong interpersonal skills and ability to interface effectively with multinational development and management teams in a multicultural working environment.
6. Excellent communication, presentation and negotiation skills with emphasis on building consensus.
7. Familiarity with market research and competitive intelligence tools
8. Experience developing training programs for the field force
Salary: $150K - $195K
Advanced knowledge of regulations, guidance documents and corporate/industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. Good scientific/technical knowledge, provides committed, value-added effort in support of development projects. Must be detail-oriented with good oral and written communications skills; able to supervise the preparation of accurate, clear and concise regulatory documents. Excellent time management skills essential; must be able to multi-task and develop timelines for deliverables. Represents CMC Regulatory Affairs internally and facilitates communication with external parties including health authorities. Possesses advanced leadership skills, mentors more junior level regulatory professionals.
ESSENTIAL DUTIES AND
1.Will have a comprehensive understanding of regulatory requirements including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive) as they apply to the registration, development, and approval of investigational products as well as post approval changes to marketed products, with an emphasis on Chemistry, Manufacturing, and Controls (CMC) and the regulation of biologics.
2.Coordinates the preparation of CMC submissions through editing and approval of final draft documents, including review for accuracy, soundness, and regulatory appropriateness.
3.Responsible for IND maintenance including amendments and annual reports and timely regulatory approval and registration of clinical supplies, including regulatory process compliance.
4.As the regulatory representative to the cross-functional Core Team, the Director provides regulatory guidance to ensure development activities are compliant with relevant guidelines and government regulations.
5.Proposes strategy for approval of investigational products and post approval changes for marketed product, communicates departmental consensus strategy to Core Team and/or Manufacturing.
6.Reviews for regulatory compliance and approves validation protocols and reports, batch records, analytical methods, specifications and finished product labels, etc.
7.Assesses regulatory impact and approves change controls/requests for development and marketed products.
8.May liaise with regulatory agencies and facilitate regulatory communications.
9.The Director may manage the activities of more junior level regulatory professionals
1.Must have 9 - 14 years of Pharmaceutical Industry experience including a minimum of 5 years of regulatory or related experience.
2.Comprehensive knowledge of the drug development process and government regulations/guidelines, including US and international product registration.
3.Excellent oral and written communication skills including the preparation of moderately complex submissions.
4.Experience supervising and mentoring junior staff members, including effective work delegation.
5.BA/BS degree or equivalent experience.
Salary: $100K - $125K
The incumbent is responsible for maintaining competent knowledge of current / emerging regulations, guidance documents and corporate/industry standards, with an ability to evaluate same for impact on tactical operations. Good technical knowledge, provides committed, value-added effort in support of development projects and approved products. Must be detail-oriented with good oral and written communications skills; able to prepare accurate, clear and concise regulatory documents and manage the quality review process. Excellent time management skills essential; must be able to multi-task and drive timelines for deliverables. The position is primarily tactical however strategic insight is required. The Senior Manager is expected to work with minimal supervision.
ESSENTIAL DUTIES AND
1.Will have an in-depth understanding of regulatory CMC requirements, including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive).
2.Reviews websites and develops initial impact assessment of draft regulatory guidance, communicating changes in regulatory requirements to senior regulatory management.
3.Provides regulatory guidance to ensure development activities are compliant with relevant regulations and in line with current global guidance.
4.Communicates regulatory strategy and guides manufacturing in developing data for approval of post-marketing changes.
5.Works with development teams and Regulatory Operations to outline submission requirements and negotiate timelines for regulatory CMC submissions.
6.Prepares the CMC section of INDs, BLAs, CTAs, CTDs, amendments, supplements and annual reports, including the compilation and review of the required data, scientific reports, and written submission contributions.
7.Reviews and assesses the regulatory impact of all change controls/requests for the manufacture, testing and release of development and marketed products.
8.Assists in the implementation of processes and applications to support regulatory activities
1.Must have 3 7 years of pharmaceutical industry experience including 2 3 years of regulatory experience.
2.Demonstrated knowledge of the drug development process and government regulations/guidelines, including US and international product registration.
3.Good oral and written communication skills with a focus on accuracy (vigilant attention to detail) and clarity are essential.
4.The Senior Manager will have the ability to supervise and mentor junior staff members.
5.BA/BS degree or equivalent experience.
Salary: $170K - $210K
Provide medical expertise for all safety-related issues, which include but not limited to the following:
ESSENTIAL DUTIES AND
1. Medical review, assessment, reporting, and follow-up of individual and aggregate SAE reports.
2. Ongoing safety surveillance and signal detection.
3. Development and implementation of risk management program for the development products.
4. Communication of safety issues to project teams and other stakeholders within the company and/or corporate partners.
5. Development of responses to safety-related communications, including risk benefit analysis for submission to global and US regulatory bodies in support of clinical development, regulatory approval, sales & marketing, etc.
6. Provide medical input to periodic reporting documents (PSURs, Annual Safety Reports, ad-hoc reports, etc.) and other clinical regulatory documents such as, Core Data Sheets, Company Core Safety Information, Investigator's Brochures, Clinical Study protocol, CRF, Clinical Study Reports, Clinical Summaries and Clinical Overviews (benefit-risk evaluation).
7. Provide medical safety information as requested.
8. Ongoing training for project teams
9. Contribute to investigator meeting presentations
10. Assist senior management in making presentations to potential clients when appropriate.
11. Demonstrate a thorough understanding of Standard Operating Procedures (SOPs) and ensure that all activities are conducted in accordance with current SOPs.
12. Demonstrate a thorough understanding of applicable regulatory standards in the countries where clinical studies are to be conducted and ensure that all activities are conducted in compliance with current regulations.
1. Medical degree and broad based post graduate as well as 3 5 years of industry drug safety/ pharmacovigilance experience. Oncology experience is a plus.
2. Ability and willingness to travel up to approximately 15% of the time (4 days per month).
3. Ability to review and evaluate clinical data.
4. Outstanding oral and written communication skills.
5. Thorough knowledge of drug safety regulations and guidelines in the US and other ICH regions.
6. Ability to successfully manage and prioritize multiple critical issues simultaneously.
Currently we are working on the following Engineering and Technician opportunities for an expansion plan at a prominent utility in the Tampa, Florida area with a state-of-the-art facility and cutting edge technology. These positions will be consulting and permanent, working with their power generation expansion plan Aero (Aeroderivative). This encompasses Pratt and Whitney Swifpac jet engine gas turbine generators. Each unit produces about 60 MWs.
Will coordinate Commissioning/Startup of 2 DCSs. This consulting project is scheduled to begin December '08 and finish May '09. This individual needs to have Ovation experience and Coal fired plant experience preferred. Experience in DCS conversion projects is a plus.
Electrophysiologist Comprehensive Practice, Indiana
The leader in cardiovascular care in Indiana, one of the most physician friendly states in the US, seeks a Board Eligible/Board Certified Electrophysiologist skilled in device implantation and catheter based ablations. Candidate will have access to a dedicated state-of-the-art EP lab. Services include echocardiography, stress echo, stress nuclear imaging, Holter monitoring, and non-invasive peripheral testing. The group has its own vascular laboratory and offers a full-array of services including, diagnostic testing, non-invasive treatments, interventional procedures and surgical procedures. This prominent multi-office practice is well established in the medical community and affiliated with distinguished local hospitals.
Board Certified/Eligible Electorphysiologist
Salary: $170K - $220K
Cardiologist, Clinical Research, Phase II-III, Global Pharmaceutical, New Jersey
Design, implement, and monitor studies (with a focus on Phase II/III atherosclerosis and antithrombotic multinational trials) and interact with leading investigators in the field, to ensure the ethical and scientific basis of the study. Review and interpret data gathered. Identify and institute corrective measures when applicable. Ascertain any significant adverse reactions and closely monitor efficacy parameters. Assist in the dissemination of important scientific information through the writing/assisting in the writing of publications, abstracts and/or presentations. Also will be involved with due diligence of in-licensing opportunities.
MD from an accredited institution. Board certified or Board eligible Cardiologist with 0 to 3 years relevant experience in the US pharmaceutical or biotech industry. For those candidates not having industry experience, prior clinical trial experience and academic fellowship is preferred. Demonstrated excellence in oral, written communications. Ability to oversee and direct multiple projects with varying complexity involving multiple skill levels of subordinates with minimal assistance from supervisor
Salary: $140K - $170K
Director of Regulatory Affairs, Investigational Products
Summary/Essential Duties & Responsibilities:
Directly responsible for the organization and preparation of IND submissions. Coordinates the activities required to maintain the IND filings in Regulatory Compliance; Participates in compliance activities including SOP creation/revision and departmental training exercises.
1.Direct the preparation (content and format) of submissions (INDs, IND amendments, BLAs and BLA supplements and periodic reports) to the FDA.
2.Coordinates activities required for timely and accurate reporting of information to the existing INDs.
3.Responsible for liaison activities with functional groups within company related to assigned products/project areas.
4.Provides updates of new FDA regulations, guidance and guidelines obtained from review of the Federal Register, FDA Talk Papers and trade press to all applicable groups. Provide notification of key meetings.
5.Oversees the maintenance of company information in the FDA database of clinical trials.
6.Participates in the creation, review and revision of the department policies and standard operating procedures (SOPs).
7.Participates in the tracking and authorization of study medication to clinical sites.
8.Assist in developing and presenting department training sessions.
9.Provide guidance to multifunctional development teams concerning strategic decisions and health authority interactions.
Essential Knowledge, Skills, Experience:
1.PhD/PharmD in life science with at least 2-3 years experience in regulatory affairs or BS degree in life science with 6 years of experience in the pharmaceutical industry with at least 4 years experience in regulatory affairs.
2.Must possess a thorough understanding of the drug development/regulatory process.
3.Experience in GCPs and regulatory compliance preferable.
4.Demonstrate a thorough knowledge of the intent, meaning, interpretation and application of FDA and ICH regulations; Knowledge of foreign regulations, guidelines and practices for conducting beneficial clinical investigations.
Salary: $170K - $210K
This physician will direct the clinical development of novel antibody
based therapeutic agents in the fields of Oncology, Infectious Diseases
and Immunology under the direction of the SVP of Product Development.
Responsibilities will include: management of a Clinical Science staff
of 10, including MDs, clinical scientists, statisticians and medical
writers; identification and evaluation of therapeutic targets; review
of pre-clinical studies and INDs; generation of clinical development
plans to include scientific background, clinical trial design and
approval strategies; identification of appropriate consultants,
clinical investigators and trial sites; generation of clinical trial
design and basic protocols; review of clinical trial data; evaluation
of clinical responses, adverse events and patient management as
appropriate within clinical trials; generation of clinical trial
reports, presentations and publications; present clinical data in
scientific and other forums; maintain collaboration with corporate
partners and participate in appropriate FDA interactions. Represent
Clinical Science department on a Product Development Management Team
additionally comprising Medical Operations, Regulatory Affairs,
Regulatory Compliance and Quality Assurance, Project Management and
M.D., Internal Medical and Oncology Fellowship. Familiarity with
clinical trials and pharmaceutical development. 3 years of fellowship
with 5 or more years of involvement in clinical research or therapeutic
trials. Drug development and management experience in industry is of