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- Cambridge, MA
new job!

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....

- Bridgewater, NJ
new job!

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....

- Greenville, SC
new job!

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....


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 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....


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....


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....

- West Los Angeles area, CA

Growing Oncology Clinical Trial site in the west side of Los Angeles has an opening for a Regulatory (IRB) Associate. This is a temp to hire position. Responsibilities:Will provide support for clinical research protocols, informed consents, etc.Will assist with all aspects of clinical research regulatory to ensure compliance to regulations and protection of human subjectsPrepare and submit documents to the IRBRequirements:Bachelor's degree required1+ years of IRB/Regulatory experience....


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....


Global Pharmaceutical Leader is looking for consultant (all levels) Clinical Managers for their growing Clinical Development team Accountable for leading the operational study team, which is responsible for the execution and delivery of quality studies, including in-process quality control activities (e.g. quality checks and balances to ensure inspection readiness, enrollment, metrics, milestones, timelines and budget). This position requires advanced knowledge of the functional disciplines....


Top Tier Pharmaceutical company (with focus in RESPIRATORY, CNS, Diabetes, Cardio, GI and more) in Madison, NJ is looking for three Clinical Trials Manager Consultants for Clinical Trials Group This is a one year contract and can continue for up to 4 years (1099 or w-2)SummaryParticipate in all aspects of clinical development and study management under the direction of the Director, or designee, which includes providing scientific, and/or logistical support to planned and ongoing trials CTM –....

- Charlotte, NC

Summary of the Position:. Develops and deploys the quality system for entire manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company specifications and policies. Periodically reviews the suitability and effectiveness of the quality systems with Executive Management. He/She has ultimate responsibility for making the quality decisions on the identity, purity, strength or composition of nutritional products in the....

- Lancaster, SC

Summary of the Position:. Develops and deploys the quality system for entire manufacturing facilities to assure systems and procedures are compliant pursuant to government regulations, industry standards and Company specifications and policies. Periodically reviews the suitability and effectiveness of the quality systems with Executive Management. He/She has ultimate responsibility for making the quality decisions on the identity, purity, strength or composition of nutritional products in the....

- Cranford, NJ

Global Pharmaceutical company is hiring a \ for their growing company. Our Clinical Trainer is responsible for identifying and implementing Clinical Development staff training needs. They may benchmark Clinical SOPs and insure SOP training is completed and up to date. The Clinical Operations Trainer may also periodically co-monitor and evaluate staff performance and provide guidance for performance, improvement and adherence to FDA and SOP requirements. They may liaise with US and Taiwan....


The Manager Regulatory Affairs will be responsible for the following: Leading the preparation and filing of regulatory applications (IND, NDA, BLA).Coordinating/meeting with various functional areas in order to identify and obtain information required for regulatory submissions.Developing and/or reviewing regulatory documents (IND, NDA, BLA) in order to ensure that all submissions are of high quality.Leading the preparation of responses to questions from Regulatory Authorities.Developing and....

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