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Company Jobs - MedImmune


 

Lead Document Specialist - 70014819

Gaithersburg MD

Required Education: * Bachelor's degree or equivalent experience Major Requirements: * 10-12 years of industry experience in electronic document management systems * Expert knowledge and experience in Documentum/First Doc functionality, policies, procedures and processes * Expert knowledge in Microsoft Word package and software * Expert knowledge of regulatory documentation and submissions globally * Experience in working with geographically diverse global teams * Demonstrated ability to develop innovative and effective solutions to problems of high complexity Desirable: * Experience in system administration for validated applications within a regulated environment. * Knowledge of the drug development process Competencies: * Demonstrate excellent interpersonal skills and build relationships across functions and disciplines to deliver a quality service * Demonstrate excellent communication skills with all levels of the organization, including Sr mgmt. * Demonstrate strong ability to deal with ambiguity and manage conflicts * Excellent Presentation skills * Learning on the fly * Customer focus * Good organizational skills MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/2/2014 7:34:01 AM

Senior Director, Clinical Data Management

Gaithersburg MD

Required Education: * BS degree is required. * MS or equivalent degree within the life sciences or related discipline is preferred. Experience and Requirements: * Extensive experience within the biopharmaceutical/clinical research industry managing clinical data. * Extensive knowledge of GCP, GCDMP and other relevant ICH/regulatory guidelines. * Demonstrated experience leading and/or building a Clinical Data Management group and/or function. * Comprehensive knowledge of the pharmaceutical industry and drug development process. * Comprehensive knowledge of clinical trial operational principles and processes. * Demonstrated ability to drive a vision through to execution and associated change management. * Excellent strategic thinker with the ability to influence others. * Commitment to do the right thing. * Willingness to challenge the organization in good faith. * Ability to compromise with flexibility or hold the line with discipline, along with the judgment required for either on a case by case basis. * Excellent communications skills and ability to articulate the rationale behind CDM practices and the value these practices bring to the organization. * Ability to negotiate effectively. * Agile learner *LI-MEDI ~BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/2/2014 7:34:01 AM

Senior Finance Analyst

Gaithersburg MD

Minimum Requirements & Experience: * A focused financial professional with strong analytical and customer service delivery skills * 5 or more years experience with financial modelling, forecasting, and business decision support * Proficient in the use of accounting systems & working knowledge and understanding of various financial systems and processes * Strong Excel skills * Strong organizational and communication (written, verbal) skills * Thorough understanding of functional cost drivers and able to deliver variance explanations * Able to understand the value of business drivers within a business area, to work collaboratively developing accurate forecasts, and to support strategic business decisions * Bachelors degree in Finance, Accounting, or similar Desirable: * MBA, with specialization in Finance * Financial Planning & Analysis experience * Experience working in a global organization, preferably within the pharmaceuticals industry, and knowledge of the drug development life cycle and commercial aspects of the industry * Experience of working within a multi-disciplinary team and liaising with senior managers * Demonstrated experience working in a customer facing role with finance business partnering * Good cultural awareness, exposure to global working, collaboration and teaming skills BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/2/2014 7:34:01 AM

Data Management Project Lead

Gaithersburg MD

Position: Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry Education: Minimum of a BS in life sciences degree and/or equivalent experience MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/1/2014 7:35:44 AM

Data Management Project Lead

Gaithersburg MD

Position: Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry Education: Minimum of a BS in life sciences degree and/or equivalent experience MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/1/2014 7:35:44 AM

Senior Director, Clinical Development

Gaithersburg MD

Requirements/Qualifications: * Prior experience in clinical research design/implementation of protocols, review/interpretation of data is required. This could be obtained through prior work in the pharmaceutical industry, Regulatory, or academic clinical research. * Must demonstrate knowledge of the clinical development process and have direct clinical research and managerial experience. * Knowledge of clinical trial management, data management, and drug development process. * A detailed understanding of human disease, pharmacology, biochemical medicine and the relevance of pharmacodynamic/clinical endpoints that underlie the action of the drug(s) being developed. Required Experience: * A fellowship or training and certification in Oncology are desirable. Clinical or research experience in field of specialization is highly desirable. Five or more years of industry related experience is desirable. Special Skills/Abilities: * Excellent oral and written communication skills, as well as interpersonal skills. Hard working, driven to achieve creative and sound results. Education: * MD with a valid medical license. * Medical specialty and sub-specialty training and certification are highly desirable in Oncology. * A fellowship or training and certification in Oncology are desirable. *LI-MEDI ~BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 10/1/2014 7:35:44 AM

Manager/Senior Manager - MS&T Validation

Frederick MD

Position: Freedom to Act Assignments are received in task-and objective-orientated terms. Provides direction to subordinates based on general policies and management guidelines. Work is reviewed upon completion for adequacy in meeting objectives. Interprets and executes policies and procedures that typically affect subordinate organizational units. Recommends modifications to operating policies. Supervisor Relationships Accomplishes results through lower-level exempt employees who exercise latitude and independence in their assignments. Often heads a centralized functional activity. Operations Involvement / Direct Work Involvement Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems. Impact Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds. Liaison Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling or specific phases of projects or contracts. Conducts briefings and participates in technical meetings for internal representatives concerning specific operations. Interpersonal Communication Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills. Contacts are frequent with individuals representing other departments, and/or representing outside organizations. Contacts involve obtaining or providing information or data on matters of importance to the function of the department or which may be of sensitive nature, requiring some explanation or interpretation. Education: Typical Education: B.S/B.A./M.S./PhD in engineering, biological sciences, physical sciences, or equivalent focus of study. MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/30/2014 3:37:41 AM

Principal Scientist/Fellow, Companion Diagnostics Development

Gaithersburg MD

Education/Experience: For Principal Scientist PhD and 5 years of relevant industry experience in the application of personalized health care in drug development For Fellow: PhD and 8 years of relevant industry experience in the application of personalized health care in drug development Position : * Demonstrated record of innovative contributions to translational sciences / companion diagnostics 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 * Strong knowledge on personalized medicine. Expertise in implementation of molecular diagnostic in early and late stage clinical development. * The ideal candidate will have demonstrated experience in successful development and implementation of personalized health care strategies in late stage clinical development. * Strong understanding of genomics and proteomic technologies, their application in the field of companion diagnostics, and validation strategies are a must. * Experience interacting with health authorities on personalized health care strategies is highly desirable. * Strong understanding the approaches to generate potential hypotheses based on translational science data and testing in early clinical development is a big plus. * This role requires an individual with outstanding communication and leadership skills, as well as the ability to build strong relationships with key stakeholders across functional and therapeutic areas, other relevant functions within MedImmune and external 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. MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/30/2014 3:37:41 AM

Production Technician II

Frederick MD

Position: * Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. * Ability to deal with problems involving a few concrete variables in standardized situations * Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. * Good organizational skills * Situational Self Leadership Education: BS/BA degree preferred Associates degree and High School Diploma acceptable with experience 1-3 yrs experience with Bachelors, 2-4 years experience with Associates, 5-7 years with High School Diploma ~BSP *LI-MEDI MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/30/2014 3:37:41 AM

Senior Supervisor, Production (Downstream)

Frederick MD

Position: 7-10 years work experience in pilot or commercial biologics manufacturing under cGMP with Bachelors. 5-7 years experience with Masters degree. 10-15 years experience with Associates Degree and 15+ years experience with High School education. Education: BS/BA degree preferred in biological sciences or biotechnology/life sciences. Masters degree accepted. * Associates and High School Diploma acceptable with appropriate experience MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/30/2014 3:37:41 AM

Manufacturing Specialist

Frederick MD

Position: Education Required: B.S./B.A./M.S. engineering, biological sciences, physical sciences, or equivalent field of study required. Lean/Six Sigma certification preferred. Required experience: 5-7 years of work experience in process development, pilot plant or commercial biologics manufacturing under cGMP with Bachelors degree. 3-5 years' experience with Master's degree. 2-4 years' experience with PhD degree. Skills required: * Good organizational skills * First-line management skills for daily operation * Situational Leadership * Decision making skills * Must demonstrate excellent communication skills, both verbal and written, and effective presentation skills. ~BSP *LI-MEDI MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/29/2014 7:25:05 AM

Medical Writer/Senior Medical Writer

Gaithersburg MD

This position can be filled at either the Medical Writer level or the Sr. Medical Writer level. Major Requirements: * For the Medical Writer level, we require 0 - 3 years overall of medical writing experience. * For the Sr. Medical Writer level, we require a minimum of 4 years of medical writing experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment. Includes authoring/editing CSRs and other types of clinical regulatory documents (eg, clinical protocols, Investigator's Brochures) as well as authoring clinical/scientific abstracts, posters, and manuscripts. For both levels we require the following: * Proficiency in the use of Microsoft Office applications with experience working in electronic document management systems. * Extremely high attention to detail. * Knowledge of the drug development process and principles of GXP/ICH/CTD and other global standards, with an understanding of the basic strategy for regulatory submissions. * Background in biologics a plus. * Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables. * Strong written, verbal, and interpersonal communication skills. * Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment. * Flexible/willing to adapt to changing deadlines and priorities. Education: * Requires a PhD/PharmD in a scientific discipline, or a Master's degree with relevant experience. *LI-MEDI ~BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/29/2014 7:25:05 AM

Oncology Business Insight Director

Gaithersburg MD

Minimum Requirements: BA/BS degree; preferably advanced degree in a relevant field (e.g. MBA) 5+ years of pharmaceutical or biotechnology experience; Oncology experience preferred Experience applying various primary research techniques and secondary to inform business decisions Pharmaceutical or consumer Insight experience highly desirable Preferred Requirements: Demonstrated ability to influence laterally and vertically Demonstrated communication and teamwork skills, ability to gain consensus and act within a matrix team environment Strong business and marketing acumen and excellent communication and interpersonal skills; consultative background preferred Demonstrated ability to influence without authority, motivate teams, and maintain high levels of respect for and from peers Demonstrated ability to pull together insights from a variety of sources and develop strategic guidance for brand teams that result in a business decision or action Demonstrated success in applying various primary research techniques to inform strategy in the pharmaceutical industry Proficiency in secondary data analysis with intimate knowledge of a variety of industry secondary data sources (eg. IMS, WK, IPSOS) Demonstrated ability to cope well with change, risk, and uncertainty (Ambiguity) and act decidedly with incomplete or imperfect information Ability to work in a collaborative and influencing fashion that drives to business action Ability to manage, prioritize and lead numerous projects simultaneously Ability to work within AstraZeneca's established policies/procedures and core values Ability to travel within the USA and abroad BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/26/2014 7:19:17 AM

Oncology Business Insight Manager/Leader

Gaithersburg MD

Minimum Requirements: Bachelor's degree 5+ years of pharmaceutical or biotechnology experience; preferably with Oncology experience 3+ years of primary market research and analytical experience applying various primary research techniques and secondary analysis to inform business decisions Preferred Requirements: Demonstrated ability to influence laterally and vertically Pharmaceutical or consumer Insight experience highly desirable. BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/26/2014 7:19:17 AM

Product Manager

Gaithersburg MD

Education, Qualifications, Skills and Experience Essential * Bachelor's degree in science/healthcare related field or proven Patient Safety experience equivalence in a similar role, and an excellent clinical background. In exceptional circumstances 10-15 years of drug safety experience will be considered in lieu of degree requirement * At least 3 years patient safety experience * Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse event reporting Desirable * Advanced degree in science/healthcare-related field * 3-5 years drug safety experience * At least 2 years clinical practice experience * Working knowledge of surveillance of pharmaceutical products * Working knowledge of epidemiology and/or clinical research experience * Demonstrated capabilities in: Project management, Time management, Presentation skills, Strong attention to detail and organization BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/26/2014 7:19:17 AM

Team Leader

Gaithersburg MD

Education, Qualifications, Skills and Experience Essential * Bachelor's degree in science/healthcare related field plus proven Patient Safety surveillance experience equivalence, and an excellent clinical background. * At least five years patient safety experience and/or at least five years clinical or pharmaceutical experience * Demonstrated working knowledge of FDA and ICH regulations relevant to Patient Safety and adverse Desirable * Advanced degree in science/healthcare-related field * Ability to synthesize and analyze complex medical and scientific data * Working knowledge of epidemiology * Demonstrated capabilities in: Project management, Time management, Presentation BSP MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/26/2014 7:19:17 AM

Medical Writer/Senior Medical Writer

Gaithersburg MD

This position can be filled at either the Medical Writer level or the Sr. Medical Writer level. Major Requirements: * For the Medical Writer level, we require 0 - 3 years overall of medical writing experience. * For the Sr. Medical Writer level, we require a minimum of 4 years of medical writing experience in the medical/regulatory/publication writing field in the pharmaceutical/biotech industry or CRO environment. Includes authoring/editing CSRs and other types of clinical regulatory documents (eg, clinical protocols, Investigator's Brochures) as well as authoring clinical/scientific abstracts, posters, and manuscripts. For both levels we require the following: * Proficiency in the use of Microsoft Office applications with experience working in electronic document management systems. * Extremely high attention to detail. * Knowledge of the drug development process and principles of GXP/ICH/CTD and other global standards, with an understanding of the basic strategy for regulatory submissions. * Background in biologics a plus. * Ability to work collaboratively and coordinate the efforts of team members to resolve comments and complete deliverables. * Strong written, verbal, and interpersonal communication skills. * Ability to manage/prioritize multiple projects under general supervision, working in a fast-paced environment. * Flexible/willing to adapt to changing deadlines and priorities. Education: * Requires a PhD/PharmD in a scientific discipline, or a Master's degree with relevant experience. MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/25/2014 7:45:19 AM

Sr. Manager, Management Systems & Training

Gaithersburg MD

Position: Required Experience: 10+ years' experience in Safety, Health and Environmental. Required Education: Bachelors degree in Industrial Hygiene, Chemistry, Biology, Physics, Environmental Science, Occupational Health, Engineering or similar field; Masters degree in related field preferred. MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/25/2014 7:45:19 AM

Coordinator, Packaging

Philadelphia (Non Sales) PA

Position: * 0-2 years with Bachelors's degree * 2-4 years with high school diploma or general education degree (GED) Education: * High School Diploma or general education degree (GED). Bachelor's degree is preferred ~BSP *LI-MEDI MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/25/2014 7:45:18 AM

Manager, Field Reimbursement

Saint Louis MO

Position: Minimum Requirements: Education & Sales Experience * Bachelors Degree required (MBA or other related graduate-level degree is preferred) * Minimum of 5 years of total business experience in the healthcare or pharmaceutical/biotech industry * Minimum of 2 or more years' sales, managed care or reimbursement experience is required Preferred Experience / Background: * Two to four years Biotech or Pharmaceutical Sales experience. * Two to four years of Managed Markets experience. * Infectious Disease, Respiratory, Inflammation, Autoimmune, Oncology, Cardiovascular and Neuroscience experience. * Experience with business planning and market analysis. * Experience in implementing value added programs and advisory programs. Job Requirements: * Compliance, Knowledge, & Skills * Does not compromise ethics or integrity, or undertake legal risks while pursuing business goals * Demonstrates leadership among peers by consistent application & modeling of appropriate compliance, behavior & conduct * Reimbursement Related Experience * Experience with physician administered injectables preferred * Excellent reimbursement expertise and payer knowledge preferred * Knowledge and experience of legal and regulatory requirements related to the Biotech / Pharmaceutical industries * Field Development, Planning, & Support * Spends majority of time visiting customer accounts in the field * Works with manager, peers and partners in Marketing, Sales and various Managed Markets and Trade groups to review/understand relevant franchise and managed care business plans, tactics, goals and objectives * Spends considerable time and effort working with field partners in Sales reviewing their territory business plans and progress, helping to identify reimbursement-specific opportunities or issues, as well as educating partners on the payer landscape Job Knowledge: * Maintain a high level of Managed Care and related Managed Markets benefit structures, reimbursement mechanisms, legal and regulatory influences, and health management programs. * Maintain consistent ability to access and influence key business decision makers. * Maintain a high level of industry awareness. * Maintain an outstanding level of Multiple Therapeutic Area knowledge, utilization management techniques, treatment and reimbursement guidelines. * Maintain an outstanding level of performance metric analytics. * Maintain a comprehensive and detailed Territory Plan. * Maintain an outstanding ability to prepare and present provider level communications. Planning and Analysis: * Maintain an outstanding level of territory planning, organization, and administrative skills. * Manage territory and all assigned accounts within set budget. * Develop and justify budgeting requests for specific customer programs. Communications: * Demonstrate strong oral, written, and group communication skills. * Maintain frequent contact with Field Leadership and local field staff. * In a timely and accurate manner, submit all budgetary information, expenses reports, and required administrative reports to Field Leadership. * Maintain effective communication with customers and affiliates. * Seek out and maintain an effective level of communication with account stakeholders and decision makers. ~BSP *LI-MEDI MedImmune, LLC. is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. MedImmune, LLC is an Equal Opportunity/Affirmative Action Employer

Posted On - 9/24/2014 7:33:02 AM

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