The process of bringing a new drug molecule into clinical practice. In its broadest definition this encompasses all steps from the basic research process of finding a suitable molecular target to supporting the commercial launch of the drug.
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Job Summary: The Principal Medical Writer (MW) provides MW leadership and subject matter expertise to cross-functional project teams and drives the efficient development of study-level and program-level clinical regulatory documents. She or he is a strategic thinker and decision maker who effectively collaborates with internal and external stakeholders to coordinate document content, quickly resolve conflicts, and meet established timelines. Duti...
Lead and coordinate activities that ensure quality, consistency, and integration of study data and progress operational deliverables to time cost and quality objectives from Study start-up through study close-out activities and Clinical Study Report (CSR). Work with US local study team, with internal and external partners, on local studies across different phases of drug development and different therapy areas. What you will do. Coordinate operat...
Job Description. Job Description. Salary: $150,000-$170,000. Job Summary. The Principal Medical Writer (MW) provides MW leadership and subject matter expertise to cross-functional project teams and drives the efficient development of study-level and program-level clinical regulatory documents. She or he is a strategic thinker and decision maker who effectively collaborates with internal and external stakeholders to coordinate document content, qu...
Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disorders. Axsome is based in New York City. About This Role. Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medi...
Bring your heart to CVS Health. Every one of us at CVS Health shares a single, clear purpose: Bringing our heart to every moment of your health. This purpose guides our commitment to deliver enhanced human-centric health care for a rapidly changing world. Anchored in our brand — with heart at its center — our purpose sends a personal message that how we deliver our services is just as important as what we deliver. . Our Heart At Work Behaviors™ s...
Company Description. IRI believes in commitment, integrity and strategic workforce solutions. Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand in...
Overview. Replimune’s mission is to revolutionize cancer treatment with therapies designed to activate a powerful and durable full-body anti-tumor response, boldly transforming cancer care because. patient’s lives depend on it. We imagine a world where cancer is a curable disease. . At Replimune, we live by our values. United: We Collaborate for a Common Goal. . Audacious: We Are Bold and Innovative. . Dedicated: We Give Our Full Commitment. . C...
Note to Recruiters and Agencies. The Talent Acquisition / HR team manages the recruiting for all positions at Adverum. We only accept resumes from search agencies or recruiters if the Talent Acquisition / HR team has formally requested your help and have a signed agreement in place. Unsolicited resumes sent to Adverum will be considered property of Adverum. The company will not be responsible for any associated fees should Adverum hire from unsol...
. POSTION SUMMARY. The Manager, Regulatory Affairs provides support pertaining to regulatory affairs related to the development of novel drugs including preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations. JOB FUNCTIONS/RESPONSIBILITIES. Leads preparation of regulatory documentation, in accordance with regulations, guidance and legal obligations. Supports the GRL and cross ...
Description. TSP is engaged in a direct hire search for one of our clients. We are seeking a highly motivated and experienced professional to join our team as a Medical Science Liaison. Key aspects of this role will include engage in peer-to-peer scientific dialogue with healthcare professionals that translate into meaningful insights, serve as a therapeutic expert and thought partner to internal teams, liaison between the client and clinical stu...
Description. TSP is engaged in a direct hire search for one of our clients. We are seeking a highly motivated and experienced professional to join our team as a Medical Science Liaison. Key aspects of this role will include engage in peer-to-peer scientific dialogue with healthcare professionals that translate into meaningful insights, serve as a therapeutic expert and thought partner to internal teams, liaison between the client and clinical stu...
