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- Greensboro, NC
new job!

Join a Global Company as the strategic North American (NA) Team Leader supporting Analytical/ Synthesis (Methods Development); Product Metabolism, Product Safety (registration); and Regulatory Compliance (EPA). Participate on the Global Leadership Team while developing a challenged, problem-solving analytical team responsible for performing/ delivering scientific studies to ensure a sustainable product safety and registration success. The successful candidate will have a strong background in....

- Tacoma | Seattle, WA
new job!

VP of Compliance - Seattle/Tacoma ________________________________________________ Leading healthcare enterprise - excellent team work - generous relocation package. Experienced leader and relationship -builder with a successful career in health plan compliance will have an opportunity to continue the already successful programs and contribute to the continued growth in this market. The VP will work as a partner to the CEO. VP will serve as a key part of the local leadership team ensuring....


Publicly traded Boston based pharmaceutical company is expanding and looking for: experienced Associate Director of Clinical Trial Disclosure and Transparency to lead, define, execute, and efficiently manage clinical trial disclosure and transparency activities. This newly created position will report to the Head of Medical Writing and will be a key player in evaluating, developing, and implementing efficient, quality compliant processes and systems to ensure overall effectiveness. In....

- Cambridge, MA

Summary of Key ResponsibilitiesProduce high quality and on-time writing deliverables.Plan, write, edit, and format key documents with minimal supervision, including clinical protocols, investigator brochures, clinical study reports, integrated safety and efficacy summaries and related documents. Other documents may include informed consent forms, health authority briefing books, and scientific publications.Facilitate efficient review and finalization process for documents produced internally....

- Greenville, SC

Reporting directly to the Quality Systems and Compliance manager, the Quality Auditor will have responsibility to audit scheduling, planning, execution and documentation of quality system audits of internal processes for the Greenville location. This position will also be responsible for maintaining a library of standards and for reviewing all applicable regulations, standards and communicating requirements to site leadership. This position will provide cGMP / GXP, technical and auditing....

- Bridgewater, NJ

Global Pharmaceutical company in Bridgewater, NJ is looking to a hire a Manager, Medical Education one year, w-2 contract, full benefits and competitive salaryob Summary: The Medical Education Associate Manager is responsible for the development and management of a portfolio of non-accredited medical education programs and speaker management. Principle Responsibilities: (essential job duties and responsibilities) - Develop and execute medical education program plan o Initiate and lead....


Our client, a well-known Provider of Language Services with offices around the world, is seeking an Account Executive for their Life Sciences Translations group. The individual will be based out of the New York office and will be tasked with generating new business in the Life Sciences (Pharma/Med/Bio) space for this provider of translations to over 100 languages. Reporting to the Sr. VP of Global Sales, the Account Executive would be responsible for covering the U.S. We provide a growth path....


Global Medical Affairs Director, Immuno-Oncology Our client, a global pharmaceutical company is expanding their I/O portfolio. This is a full-time, onsite, Director level role with the primary focus on immuno-oncology drugs.Company prides itself on a collaborative culture and the opportunity to contribute to purposeful work. Work with Oncology PD-1 products and present data to stakeholders. Lead the medical information review of regulatory documents, publications, labeling, commercial, and....


Global Pharmaceutical company which focuses in Rare Disease, Oncology and Infectious Disease is hiring a Biosmaple Operations Manager Must have GCP experience and Sponsor experience (Biotech or Pharmaceutical) One year w-2 contract with full benefits offered Or can go permanent Full time Send resume if interested and qualified:Company is seeking a Biosample Operations Manager to support the clinical teams and to work across its projects as well as with the external biorepositories, assay....


The Clinical Research Physician will be dedicated to providing a leadership role on a matrix team dedicated to stage appropriate clinical development of multiple innovative compounds. He or she will lead the development of clinical strategies for compounds and drive their successful implementation. Essential Job Functions/ResponsibilitiesResponsible for drafting clinical development plans, clinical trial protocol synopses and protocols, and for leading discussions and revisions of study design

- Palo Alto, CA

The Director, Medical Writing is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He/she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of development plans and submission plans, and for analyzing proposed plans, programs, individual studies and....


This dynamic department is looking for an HEOR professional (AD Level) he/she will be responsible and accountable for project execution and strategic support for Company’ products throughout their lifecycle. He/she will help to develop and implement US economics and outcomes strategy for one or multiple therapeutic area(s). This is a strategic as well as a technical position with project-specific responsibilities. This individual will ensure that rigorous health economics and outcomes research


Director, Medical Information for this leading pharmaceutical company in New England S Headquarters in Waltham, MA Looking for Senior Engineer for drug product unit operations- leadership scale-up and optimization in development from R&D to cGMP Phase 3 manufacture to process validation. Experience with continuous manufacturing, scale-up and PAT implementation is strongly desired. The individual is expected to integrate QbD principles, guide experimental design with a focus on process....


Vice President, Compliance (WA, NM, FL)Ensure regulatory compliance with state and other government agencies related to the health insurance industry, and its business subsidiaries. Report directly to the COO. Develop and implement a strategic vision for compliance and ethics culture within the business unit ensuring alignment with CorporateEnsure business unit is in compliance with state and federal program regulations, insurance regulations, regulatory requirements for business entities and....


Two MD contractors needed for Global Pharmaceutical company in Cambridge, MA two roles-Contract Role Only One year contract (renewal up to 4 years), w-2 with benefits offered Has to be office based in Cambridge- we will only consider local candidates at this time. We need PV experience within submissions specifically We have a submission approaching for a product. Need someone with good clinical trial experience. Worked in clinical trial as opposed to post trial setting SPA or European....


Leading Pharmaceutical Company with marketed products and strong Neurology Pipeline is looking for a Director, Medical Information for their growing US Headquarters in Waltham, MA Competitive Base, Bonus, Long Term Incentives and Relocation The Director, Medical Information (MI) will be responsible for leading the MI function within the Medical Affairs. The Director, Medical Information will be responsible for managing the member of the MI function who are providing and supporting the....


Validation Engineer Process Engineer Global Chemical /Biotech company looking to hire: Greenville, Soth Carolina location competitive salary and full relocation and full benefits Would love someone who has: affiliation with: IVT (International Validation Technology), KEN X (Knowledge Exchange Network), PDA, ISPE ResponsibilitiesRemain current on cGMP practices for Process Validation and ensure local Process Validation SOPs and validation documents reflect current industry practices.Provide....

- Somerset, NJ

Specialty Pharmaceutical Company is hiring a Safety Coordinator for Somerset, NJ Competitive Salary, bonus and incentives Provide support for environmental, health and safety matters for the Somerset site including maintaining compliance with federal, state, and local regulations. ESSENTIAL FUNCTIONS: Include the following. Other duties may be assigned. Responsible for coordinating regulatory programs, audits, permits and ensure compliance. Support the development and coordination of all EHS....

- Manhattan, NY

As a Study Leader Team Lead/Assistant Director, you will manage and mentor a group of approximately 10 study leaders and associates in order to maximize their capabilities to deliver high quality clinical studies. People Management · Coach and develop global staff to maximize their contribution to the delivery of studies across various therapeutic areas · Manage performance of direct reports through regular dialog and throughout the year in accordance with the Roche performance management....


Strong Player in the Pharmaceutical Industry is looking to hire a Medical Director for their new Phase one Unit (24 bed) Looking for a true Medical Director (not just a PI) who can interact and engage other Key Opinion Leaders in the Medical Community This role include VERY competitive base salary, long term incentive and full relocation (will make it stress free- pack up, moving and temp housing, real estate assistance and more) The primary responsibilities of this position include medical....

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