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Company Jobs - MedImmune


 

Lead PV Case Handling Specialist

Gaithersburg MD

Experience required in (bio)pharmaceutical company/CRO Extensive experience in case handling activities for both clinical trial and post-marketing pharmacovigilance required, with some knowledge and experience of activities such as negotiation of Business Partner Agreements, Aggregate Reports, and case handling compliance activities an advantage (as a guide, will have a minimum of 5 years experience) Position requires excellent working knowledge of U.S. and international regulations in relation to good case handling, processing and reporting practices and ability to provide guidance regarding regulatory requirements Demonstrated experience of training and/or mentoring junior staff members Extensive experience with use of safety databases and familiarity with medical terminology or MedDRA Education: Health Care Professional (HCP) or Bachelors Degree in scientific related field

Posted On - 4/22/2014 7:20:32 AM

Manufacturing Innovation Specialist

Frederick MD

Position: * Expert knowledge of biopharmaceutical manufacturing processes, systems and equipment * Expert knowledge of electronic manufacturing and quality systems * Knowledgeable of manufacturing automation systems and their application * Knowledgeable of application and practices of current Good Manufacturing Practices (cGMP's), international regulatory requirements and guidelines (such as European directives, ICH guidelines and European and Japanese pharmacopea requirements * Knowledgeable of late stage clinical and commercial manufacturing regulatory requirements and best practices * Knowledgeable in supply chain operations and business processes * Possesses strong verbal and written communication skills * Knowledgeable of troubleshooting/ root cause analysis tools * Working knowledge of Lean Manufacturing, SixSigma or other continuous improvement tools preferred Education: B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study. MBA Prefered. LeanSigma certification prefered. Typical experience: 8-10 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors. 6-8 years experience with Masters degree. 3-5 years experience with PhD

Posted On - 4/22/2014 7:20:32 AM

Manager, Regulatory Affairs - Project Management

Gaithersburg MD

At least 2 years in Regulatory Affairs and 6 years overall relevant experience, preferably in biotechnology or pharmaceutical industries. Education: BS required Advanced degree in a scientific discipline or equivalent experience preferred.

Posted On - 4/21/2014 7:19:52 AM

Senior Manager, Regulatory Affairs - Project Management

Gaithersburg MD

At least 5 years in Regulatory Affairs and 10+ years overall relevant experience preferably in biotechnology or pharmaceutical industries. Education: BS/MS in a scientific discipline or equivalent experience. Advanced degree is preferred.

Posted On - 4/21/2014 7:19:52 AM

Post Doctoral Fellow - Targeted Nanoparticles

Gaithersburg MD

* Demonstrated ability to conduct high level research as evidenced by a strong publication record. * Experience with bioconjugation methods and materials characterization techniques. * Demonstrated ability to work cross-functionally in a multidisciplinary environment. Education: Ph.D. in chemistry, materials science and engineering, bioengineering, chemical engineering, pharmaceutical science or related discipline.

Posted On - 4/18/2014 7:16:41 AM

Lead Medical Writer

Gaithersburg MD

Required Experience and Skills: * 6+ years experience in the medical/regulatory writing field in the pharmaceutical/biotech industry or CRO environment. * Includes proficiency at authoring/editing CSRs, experience authoring/editing multiple other types of clinical regulatory documents (eg, study level, program level, health authority responses), and knowledge of multiple therapeutic areas, disease areas, and technical disciplines. * Proficiency in the use of Microsoft Office applications and working in electronic document management systems. * Extremely high attention to detail. * Thorough knowledge of the drug development process with an understanding of the strategy for regulatory submissions. * Knowledge and understanding of the principles of GXP, ICH, CTD and other global standards. * Understanding of interdependencies among projects within and across programs. * Background in biologics a plus. * Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables. * Ability to manage ambiguity and works through conflict to create consensus. * Ability to identify problems and develop approaches to solving them. * Ability to effectively communicate in oral presentations. Education: * Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.

Posted On - 4/17/2014 7:34:10 AM

Senior Manager, Operational Excellence

Philadelphia (Non Sales) PA

Position: Works with other members of the Site Leadership Team (SLT) to define the OE future state. Responsible for developing and driving plans to for an OE culture aligned with the Shingo Prize. Establishes site OE goals to include financial and cultural objectives. Builds employee capabilities in OE and engages all employees in the site OE initiatives. Tracks and reports on the health of the site's OE Program and Culture. Including: ?Employee engagement ?% yellow belt and green belts ?% lean manufacturing trained ?Cycle time of certification ?Cost of Goods savings due to OE initiatives Provides technical leadership, mentoring, and project support as required to support Lean/6 Sigma initiatives. Manages the Site Metrics and Site Metric cascade. Implements recognition initiatives to reinforce the OE culture. Develops direct reports as assigned. Works with multiple teams and sites to develop and implement improvement opportunities. Facilitates sharing of best practices with other sites and internal/external benchmarking. Member of the Site Senior Leadership Team. Education: BS/BA in engineering, physical or life sciences or business *LI-MEDI

Posted On - 4/17/2014 7:34:10 AM

Clinical Operations Program Lead, Infectious Diseases & Vaccines

Gaithersburg MD

Required Education: * University degree, preferably in a biologic/scientific discipline. * Advanced degree is preferred. * Certification or Degree in Project Management is a plus. Required Experience: * At least ten years of experience in the pharmaceutical/biotech industry * Extensive and proven experience in driving operational delivery to timelines, cost and quality * Proven experience leading delivery through collaboration with internal organization and external providers * Significant experience and expertise in Clinical Trial methodology with a proven ability to deliver differentiated options based on a sound knowledge of operational delivery * Proven ability in proactive problem solving and risk management that is solution focused * Proven Global Project Management experience with expertise in program level resource and budget management * Preferred program level experience across the product life cycle and across multiple therapeutic areas, with experience in global drug development * Experience and strength in working and leading in matrix teams * Willingness to travel both domestically and internationally Required Skills/Abilities: * Requires minimal guidance and oversight from the Director/Sr. Director, Clinical Operations and/or Sr. Director, Clinical Development or TA VP * Strategic Skills including a high level of creativity, innovation, and problem solving with an ability to manage effectively through ambiguity * Strong collaborative communications skills including the ability to engage with a diverse client base and manage through conflict * Ability to manage the Clinical Operations remit within the PDT and/or GPT structure * Ability/willingness to lead strategic and/or operational management of individual clinical trials should the need arise * Ability to motivate team members and build cross functional teams in support of the PDT/GPT vision * Ability to provide strong leadership and facilitation skills to link strategic direction to a clear operation plan

Posted On - 4/16/2014 7:10:54 AM

Biotech Sales Specialist II - Macon-Columbus - GA

Albany GA

Position: Judgment Requirements: This position requires substantial individual judgment given the frequency and significance of interactions with MedImmune customers, and the seriousness associated with indications for MedImmune products. The BSS is expected to have the degree of judgment and diplomacy necessary to maintain cross-functional support. The BSS must know and always adhere to MedImmune policies and commit to doing business the right way. Decision-making Requirements: In this position, BSSs are expected to make broad day-to-day decisions and must, therefore, be able to make decisions that reflect and support the overall strategies of the area, region, and company. BSSs are expected to have the capacity to quickly and effectively respond to questions and unusual situations. Quality decisions, which may be made in the presence of customers, need to be based on appropriate training and personal judgment. Other key decision activities may include, but are not limited to, establishing hospital account and BSS territory objectives and tactics, prioritizing and selling to targeted customers, managing the BSS territory budget, and coordinating appropriate MedImmune and corporate partner personnel to accomplish objectives. Initiative Requirements: BSSs are expected to function effectively without close supervision. Therefore, it is imperative that each BSS possess a strong initiative, work ethic and be goal-oriented. BSSs should have a high degree of self-discipline and personal drive in order to focus on activities and communications that will support achievement of stated area, region, and company goals while continuing to build individual capabilities. BSSs must be self-motivated to seek out, recognize, and act upon local market opportunities central to the short-term and long-term success of the area, region, and company. Outside: Professional and diplomatic interaction with many levels of health and business professionals will be required. Experience: * A minimum of 2-3 years proven, successful sales experience in the Pharmaceutical, Biotechnology or Medical Products industry. * Work experience in a medical setting (i.e. NICU, PICU or private physician office pediatric nursing, medical technology, respiratory therapy, physicians assistant, etc.) is beneficial but not required. Supervision of Others: None. Travel Requirements: Travel will vary by business territory. Overnight, multi-night, and/or weekend travel may be required to accomplish desired objectives. The BSS will be expected to be able to attend company meetings and use the company-mandated forms of transportation to and from those meetings. Education: Education and Special Skills: * A four-year college degree, preferably in a scientific / medical or business discipline or relevant experience is required. * Background in Managed Care, Marketing or Sales is beneficial.

Posted On - 4/15/2014 7:11:04 AM

Project Financial Coordinator

Gaithersburg MD

Position: 2 years (please confirm with hiring manager) Education: 4 Year degree in Accounting, Finance, Economics or Business Management or equivalent, demonstrated work experience

Posted On - 4/15/2014 7:11:04 AM

QA Specialist IV - Auditing

Frederick MD

Position: * 5+ years' experience in Quality Assurance including Quality Systems. * Direct (face to face) experience working with Regulators and Inspectors. * Science (e.g. Biology, Chemistry) or Engineering (e.g. Mechanical) Degree Preferred * Thorough knowledge of FDA, EU and other global GMP guidance and regulations. * Must demonstrate strong organizational skills and demonstrate the ability to support multiple projects and meet timelines with minimal supervision. * Must be an individual with proven initiative and demonstrated accountability Education: * Bachelor's Degree with 7-10 years of biotech/pharmaceutical industry experience.

Posted On - 4/15/2014 7:11:04 AM

Associate Director, SHE (CIH)

Frederick MD

Position: Typical Experience: 5+ years experience in Safety, Health and Environmental operations. Minimum 5 - 7+ years' experience in a regulated industry (biotechnology, pharmaceuticals, other). Experience working in cGMP environment strongly desired. Certificates, Licenses, Registrations: CSP (Certified Safety Professional), CIH (Certified Industrial Hygienist) and / or PE (Professional Engineer) desirable Education: Typical Education: Bachelors degree in Engineering, Biology, Chemistry, Physics, Environmental Science, Industrial Hygiene, Occupational Health, or similar field; Masters degree in related field preferred. *LI-MEDI

Posted On - 4/14/2014 7:35:56 AM

Associate Director/Principal Scientist, Formulations

Gaithersburg MD

This position can be filled at either the Associate Director level, which is more managerial oriented, or the Prinicpal Scientst level, which is more of an individual contributor role. Required Experience: * PhD with at least 10 yrs relevant experience * MS with at least 13 years of relevant experience * BS with at least 15 years of relevant experience * Expertise in the area of protein characterization, formulation and fill/finish process development for both early and late stage biological products and proven track record in the area of technology development. * Ability to establish external collaborations and work with external CMO's to facilitate optimal formulation development and drug product manufacture. * Strong back ground, and proven track record in formulation science of biologics. This includes experience with a wide range of classes of biologics (mAbs, fusions, conjugates, etc). * In-depth molecular level understanding in developing, evaluating and implementing novel cutting edge predictive tools/strategies to aid efficient protein/product characterization. * Proven record in establishing research collaborations with academic KOL's, and business relationships with CMO's/CRO's. * Experienced in utilizing tools for analysis of business operations in a specialized scientific environment. * Excellent communication skills, strong interpersonal skills, demonstrated leadership qualities, ability to influence and motivate others in achieving desired outcomes and decisions, experienced in leading cross functional teams, and the ability to thrive in an interdisciplinary fast paced environment. Education: * PhD or MS in Biochemistry, Pharmaceutics, Chemical Engineering or related field.

Posted On - 4/14/2014 7:35:56 AM

Fellow, Oncology Translational Sciences

Gaithersburg MD

Major Requirements: This is an important, high profile and visible role and requires an individual with outstanding communication and leadership skills, as well as the ability to build strong relationships with key stakeholders in Clinical Oncology, other relevant functions within MedImmune and external Key Opinion Leaderd (KOL's) and academic collaborators. The individual must also be viewed as a strong scientific and strategic leader, one who can readily bridge between a cutting edge Research environment and a fast-paced clinical and product development organization. The successful candidate is expected to drive the publication of biomarker data in top-tier scientific, technical or medical journals. Required experience & Education: * MD, PhD/MD or PhD degree in a relevant scientific field (e.g. Oncology, pathology, molecular biology, cell signaling, cancer genetics, cancer biology, molecular oncology). * Minimum of 10-15 years post-MD/PhD experience in an academic and/or industry setting. * Ideally, at least 8-10 years of prior experience managing a group of research associates, scientists, managers, etc. * * Outstanding record of innovative contributions to translational sciences / cancer genomics as evidenced by a strong publication record including first / senior-authored publications in top-tier journals, inventorship on crucial patents/filings and presentations at important conferences are a must for this role * Ideally experienced in clinical drug development, including advanced understanding of critical development functions, e.g. Clinical Sciences, Biomarker Development, Translational Medicine, Biostats

Posted On - 4/14/2014 7:35:56 AM

Post Doctoral Fellow - Innate Immunology

Gaithersburg MD

MD, or PhD degree with strong interest in autoimmunity. Previous postdoctoral experience preferred. Proven ability to independently design and execute experiments, and interpret results. Applicant must have a demonstrated record of innovative scientific accomplishment as demonstrated by a distinguished publication record, and a high motivation to study the underlying mechanisms of cellular biology and signal transduction in immunity. Education: MD, or PhD degree with strong interest in autoimmunity.

Posted On - 4/14/2014 7:35:56 AM

Senior Manager, Environmental Affairs

Frederick MD

Position: Typical Experience: Minimum 10+ years of experience in environmental management, managing projects and / or programs with demonstrated knowledge of environmental regulations; experience in pharmaceuticals, biotechnology or related field are preferred Certificates, Licenses, Registrations: Certifications in environmental or engineering field are preferred. Education: Typical Education: Bachelors degree in Environmental Science / Engineering, Biology, Chemistry, Physics, or similar field; Masters degree in related field preferred. *LI-MEDI

Posted On - 4/14/2014 7:35:56 AM

HR Generalist

Frederick MD

Position: * Experience in global enviornment with multiple locations. * Experience in fast paced, change-ready organization essential. * Ability to Manage across an organization with comfort. * Facilitation Skills a must. Education: Bachelors Preferred *LI-MEDI

Posted On - 4/11/2014 7:26:37 AM

Associate, Patient Access

Gaithersburg MD

Position Requirements Minimum Requirements: * Minimum 3 years of healthcare/healthcare reimbursement experience; high level of proficiency in all aspects of reimbursement and access, i.e., benefit investigations, specialty pharmacy distribution, private and public payer reimbursement policies and procedures, regulatory and administrative rules, etc is required * Coordination of patient access experience * Expert knowledge of specialty products, reimbursement for medical and pharmacy benefits, patient access processes and patient assistance programs: operational policies and processes * Proven track record for consistently meeting or exceeding qualitative, as well as any relevant quantitative, targets and goals Experience with HIPAA policy, patient access data and analytics * Business travel, by air or car, is required for regular internal and external business meetings Preferred: * Relevant healthcare/ insurance experience with biologics * Billing/ Coding background in buy and bill and Specialty Pharmacy markets Education: * Bachelor's degree, RN or equivalent education or greater (health sciences, managed healthcare, public policy, social worker or related disciplines are preferred)

Posted On - 4/9/2014 6:17:57 AM

Institutional Director, Specialty Produc

Gaithersburg MD

Position: Institutional Specialty Director (ISD) will be responsible for leading and managing a team of Institutional Specialty Managers in promoting assigned products to key business accounts. The specific duties assigned to this position will be: Recruiting/Hiring: The ISD is responsible for recruiting, interviewing, and hiring qualified candidates to fill all ISM vacancies. Clinical and Selling Expertise: The ISD is required to have a high degree of clinical knowledge of all promoted MedImmune products and ensure each team member is clinically proficient. They are also responsible for teaching/developing ISMs to effectively work and sell within all areas of our business primarily focused on the hospital setting. Strategic and Tactical Execution: * Develop/Execute Management Objectives and Priorities: The ISD will be expected to help develop and achieve personal and team management objectives while staying within assigned budgets. * Developing and executing geographical management/business plans: The ISD will be responsible for ensuring effective targeting and prioritization of key customers for the promotion of Myalept, Synagis, and FluMist Quadrivalent. They will be asked to promote products clinically and educate customers on the logistics needed to successfully get MedImmune and AZ FDA approved products accessible to the patients that need them within the prescribing guidelines. An effective business planning process will be developed and executed with all team members including, but not limited to, individual accounts, marketing overview, targeted personnel, clinical use guidelines/protocols, external market factors/conditions, key opportunities, promotional implementation plan and budget allocation. * Maximizes time in field with ISMs and visiting customer accounts * Facilitating appropriate utilization of Patient Access programs: Ensuring appropriate patient access to approved products via available patient access programs such as Access 360, MAP, AZ&Me, distribution information Maintaining effective, on-going communication with all appropriate geographical teams and stakeholders. Individual in this position will be expected to initiate and maintain a high level of effective, two-way communication with the Product Brand Teams, Regional Business Director, Area Business Manager, Biotech Sales Specialists, Corporate Account Managers, Reimbursement Account Managers, and other RBU team members (e.g. MSD, Government Affairs, Corporate Partners, etc.) regarding activities and results. Appropriate and timely use of all available communication channels tools is expected. Actively participating in customer related and internal activities. Activities may include, but are not limited to: (1) developing and executing action plans to meet customer needs and the business objectives of MedImmune Specialty Care and AZ; (2) identifying strengths/weaknesses of available systems and support; (3) constantly and consistently identifying or refining personal development needs and opportunities; and (4) initiate conflict resolution using negotiation skills to explore positions, alternatives, and solutions to reach outcomes that gain support and acceptance of all parties. Tracking market intelligence that may positively or adversely affect MedImmune and AZ marketing practices and business. This includes constantly monitoring the competitive environment (e.g., new product entrants) and/or any healthcare policy changes/initiatives, which may impact MedImmune and AZ's market position. Developing and maintaining favorable customer relationships. This includes identifying and utilizing internal resources to meet customer needs, fostering interdependence, and developing each customer as an advocate for MedImmune Specialty Care and AZ FDA approved products. Administrative Business Management: * Overseeing and compliance to budget parameters while accomplishing established goals and objectives. * Reviewing expense reports - must know and follow all policies and procedures and utilize effective time management skills to meet established deadlines for administrative and required reports from Home Office and the NSD. * Needs to be skilled in all reporting systems and platforms - ensuring the completeness and accuracy of all data and information through the system. * Development and utilization of training for team members on sales data use, along with knowing how to read, interpret, analyze and develop sales reports and projections is expected. * Responsible to write and deliver performance appraisals and salary plans on time to all direct reports. * Required to deal efficiently and effectively with personnel issues in conjunction with their NSD and the Human Resources Department. * May also be extensively involved in expansion geography planning Accountability: Maintain ability to drive accountability and achieve performance objectives in assigned account base. Responsible for maintaining a high degree of honesty, integrity, diplomacy, and ethical behavior. Serve as a role model in demonstrating the company values. Education: * This position mandates a four year degree from an accredited college. Degree's in Science, Business or Management related fields are desirable * Minimum of 8-10 years of total business experience in the healthcare or pharmaceutical/biotech industry * A minimum of 3--5 years of proven, successful hospital sales experience in the Pharmaceutical, Biotechnology, or Medical Products industry * Minimum of 5 or more years sales management experience is required * Expertise in Management By Objective development and implementation * Strong written, oral and presentation skills

Posted On - 4/9/2014 6:17:57 AM

Intern - Hazardous Materials Inventory Project

Gaithersburg MD

Position: This is a temporary, entry-level position. Persons conducting the inventory must be able to work independently as well as a part of a team. Must have good communication skills. Persons will need to be physically able to spend entire day on feet. Conducting the inventory requires persons to handle biological products and chemicals. Persons may need to access areas that require step stools or crouching for periods to time. This will be a hand written inventory; therefore, extensive writing with legible penmanship is required. Must be able to read and understand chemical labels and/or material Safety Data Sheets (SDS). Education: Must have completed minimum of two years of college education in biology, chemistry or other related science fields. Must have experience in working in laboratories with chemicals and biologicals. Must be proficient in internet searches. Experience in Microsoft excel is a plus.

Posted On - 4/9/2014 6:17:57 AM

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