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Overview: The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities. Responsibilities: Responsibilities may include but....


Executive Director, Clinical Operations The Executive Director of Clinical Operations is accountable for the overall operational strategic planning, oversight and delivery of clinical development programs. The Executive Director is accountable for the line management of Clinical Operations staff, including development, coaching, talent planning and performance management. The Executive Director will also lead key strategic Clinical Operations organizational initiatives and be a member of the....


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 necessary to guide the operational objectives to ensure execution and delivery of quality studies within defined timelines and....


This unique opportunity reporting to the Vice President, Clinical Development will have a significant role in developing life transforming therapeutics for patients with rare diseases. Looking for a capable, insightful, practical, experienced and skilled physician leader to help plan, develop, execute and analyze clinical study programs in rare bone diseases. The best candidate can manage appropriate protocol development, endpoint development and effective reporting of results, adequate....

- Waltham, MA

TOP TIER PHARMACEUTICAL COMPANY in MASSACHUSETTSglobal biopharmaceutical company developing innovative medicines The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates Position SummaryWe have the need for a highly collaborative, experienced Manager of Medical Writing Operations to join our team based in MA. The position reports into our Director of Medical Writing and will lead writing responsibility of documents which ensure....

- Any US State

Pharmaceutical company hiring MSLs- GI and Pain and Addiction There is three openings for an MSL in Pain and Addiction to cover the whole United States in the: East, Central and West. There is one openings for an MSL in GI for Texas region only please only apply if you have previous and recent Medical Science Liaison experience for the pharmaceutical or biotech or medical device industries looking for three or more years of experience as an MSL The Medical Science Liaison (MSL) plays a crucial


High Profile Pharmaceutical company with recent FDA one of a kind approval is hiring a Senior Manager of Regulatory Affairs CMC Reporting to the director technical writing of RA CMC of Regulatory Affairs, the Senior Manager of Regulatory Affairs, CMC will be responsible for the preparation of high quality regulatory submission content focusing on CMC to support global clinical development, registration, and product life cycle management in accordance to regulatory requirements and guidelines.....


Global Pharmaceutical company is hiring an Executive Director to head up their Renal Medical Affairs Division this Executive role will report into the Executive Vice President of Medical Affairs and spear head the high profil department must be Nephrologist with at least 3 years of medical affairs experience Renal Cardio Medical Head (Executive Director) The Renal Cardio Medical Head is a member of the Renal-Cardio Therapeutic Area (RCTA) leadership team and leads the Renal Cardio Core Medical


Top Tier Pharmaceutical Company hiring Endocrinologist Field Physician or Senior Field Physician Endocrinology and Diabetes A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified endocrinologist who has a history of clinical practice, who has significant experience in the therapeutic area of endocrinology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant....


Top Tier Pharmaceutical Company hiring Cardiologist Field Physician or Senior Field Physician Cardiology A Field Physician/Sr. Field Physician US Medical Affairs, is a board-certified cardiologist who has a history of clinical practice, who has significant experience in the therapeutic area of cardiology and secondary prevention. They will have solid peer relationships with key opinion leaders in their therapeutic area (TA). An ideal candidate should have significant experience in their....


The Senior Manager Clinical Operations is responsible for developing operational strategy for one or more clinical studies, and leading the cross functional Study Management Team to align and deliver on study goals of data quality, timelines, budget and GCP compliance in support of overall program level plans. Responsibilities: The Senior Manager Clinical Operations Lead will independently plan all aspects of the clinical operations for one or more clinical studies and oversee the execution of


Pharmaceutical client in NYC hiring two Clinical Research Study Managers for their Global Trials The Clinical Research Study Leader (CRSL) will provide leadership to global Study Management Teams responsible for delivering First in Man, Proof of Concept through to Phase 3 registration studies in various indications. The CRSL will manage a number of studies, either for a single indication or across different indications. The CRSL is accountable for the strategic and tactical study activities,....


PHARMACEUTICAL COMPANY: focused on cns and GI and anti-infective The growth of this Corporation has created a unique opportunity for a variety of positions in Northern New Jersey, accommodating staff in Clinical Operations, Data Management, Biostatistics, Clinical SAS Programming and Regulatory. The Clinical Trials Manager will be able to organize and facilitate the overall planning, coordination and general performance of clinical trials that support the Clinical Development Plan for Clinical


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 –....


Top Tier Pharmaceutical company (with focus in Cardio, respiratory, CNS, Psych and more) in Madison, NJ is looking for a new Director, Clinical Development for to add to this growing team!The Director Clinical Development will report directly to the Vice President and is responsible for the scientific, strategic, therapeutic, and operational management of programs to evaluate, register, and market pharmaceutical agents. Lead and direct study programs, activities, and teams for one or more....


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....


Clinical Research Physician Global Oncology Pharmaceutical company is expanding and looking to add an MD Strong base salary and benefits and long term incentives POSITION OBJECTIVE: 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....


Director of Clinical Development Cardio This global Pharmaceutical company is the worldwide biologics research and development leader. Here, you’ll have the opportunity to make a difference in people’s lives every day. As one of the world’s premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. As a Director, Clinical Development in Gaithersburg MD or Cambridge UK, you’ll play a pivotal role in....


High Profile need for Global Pharmaceutical company in NJ Assoc VP, Toxicology company is a bold, global pharmaceutical company and a leader in a new industry Position Overview The Non-Clinical and Translational Sciences organization at Company is seeking an Associate Vice President to lead our department of experienced toxicology/pathology scientists. This role has responsibility for non-clinical safety evaluation for all company pharmaceutical products, in research, development or on the....


Global Pharmaceutical company is looking to hire a Director of Medical Safety Irvine, CaliforniaMD (US or foreign is acceptable)2 years PV/Risk Mgt. experience is acceptableMust have aggregate reporting and clinical safety experiencewill relocate and offer very competitive salary and benefitsDirector Medical Safety We are aa bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. We are focused on developing, manufacturing and commercializing branded....

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