- Sumitomo Pharma (Columbus, OH)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Associate Medical Director .** The Associate Medical Director ... (SmPC), and Canadian Product Monograph (PM) + Ensures timely and quality review and assessment of ICSRs, including seriousness, expectedness, safety narratives,… more
- Takeda Pharmaceuticals (Boston, MA)
- …adequate training support to all functional areas within Patient Safety & Pharmacovigilance (PSPV) in a Pharmacovigilance (PV) regulated environment. + Supports ... Excellence (DLE), Global Regulatory Affairs (GRA), Global Development Organization (GDO), Clinical Quality (CQA), and the PV & Medical Quality (PVMQ) functions.… more
- Lilly (Indianapolis, IN)
- …to make life better for people around the world. **The purpose of the Associate Director - QA in IAPI (Indianapolis Active Pharmaceutical Ingredient) role is ... the data in the format required by the regulators. + Maintenance of required pharmacovigilance quality system summaries and delegations. + Quality check… more
- Takeda Pharmaceuticals (Boston, MA)
- …true to the best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical and Safety Quality Compliance is responsible for ... functional compliance teams for regulations impacting Clinical, Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and… more
- United Therapeutics (Columbus, OH)
- …You are passionate about PV and enjoy being part of a collaborative team. The Associate Global PV Case Management Director plays a key role in management and ... safety data collection, management and reporting for postmarketing ICSRs for efficiency, quality , and compliance impacts. This role is critical in ensuring that… more
- Takeda Pharmaceuticals (Boston, MA)
- …is true to the best of my knowledge. **Job Description** **About the role:** Associate Director , Clinical Program Quality Investigations is responsible for ... Quality team and share insights to trends to Clinical Pharmacovigilance and Medical Quality and R&D Quality leadership for proactive risk mitigation and… more
- Ascendis Pharma (Princeton, NJ)
- …We offer a dynamic workplace for employees to grow and develop their skills. Associate Director , Global Patient Safety Medical Science reports to Head of GPS ... + Assists Head of GPS Medical Science for drug safety and pharmacovigilance activities for ensuring corporate compliance with all applicable laws and regulations… more
- Rhythm Pharmaceuticals (Boston, MA)
- …barriers, together. Opportunity Overview Rhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently ... + Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents… more
- AbbVie (North Chicago, IL)
- …patient safety partnership, to support potential product related issues *Key medical quality interface with Pharmacovigilance & Patient Safety (PSEQ), Global ... LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Medical Quality Assurance Physician plays a critical role in ensuring patient safety… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Data Management Processes, Training and Inspection Readiness, ... safety and pharmacovigilance , CROs and other vendors to ensure high quality of deliverables to support drug development processes and global submissions. This… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director , Laboratory Data Management is accountable for the ... safety and pharmacovigilance , CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global… more
- AbbVie (North Chicago, IL)
- …to our talent pipeline and considered for future opportunities. The Associate Director (AD) of Epidemiology in Pharmacovigilance & Patient Safety leads the ... and evaluation, signal detection, and signal validation. Familiar with quality assurance, legal and regulatory functions, database functionalities, and management… more
- Bayer (Whippany, NJ)
- …brilliant and diverse minds to make a real difference, there's only one choice.** ** Associate Director , US Medical Affairs TA Lead, CVR** At Bayer we're ... make a real difference, there's only one choice. The Associate Director , US Medical Affairs TA Lead,...Lead a team of content creators to develop high quality materials; + Support in the development of Ad-Board… more
- Regeneron Pharmaceuticals (Armonk, NY)
- The Associate Director , Global Development Quality Inspection Management (GDQIM) acting as an Inspection Management Lead (IML) is a key position that is ... and/or Investigator Site Preparation Visits, in collaboration with the GD Quality Assurance (GDQA) team and other relevant functional groups. * Identifying… more
- Haleon (Warren, NJ)
- …supplements. In line with a risk-proportionate framework for product vigilance, the ** Associate Director , Consumer Safety Science** is accountable for developing ... + 5 years+ experience in similar role with extensive knowledge in pharmacovigilance . + In-depth knowledge in causality assessment, evaluation of safety signals and… more
- Organon & Co. (Plymouth Meeting, PA)
- …improve the lives of women globally. We are looking for an experienced Associate Director , Program Management to join our team. This successful candidate ... and accurate program information in reports and systems to enable high quality portfolio communications. + Contribute to and facilitate an environment that fosters… more
- Gilead Sciences, Inc. (Foster City, CA)
- …research through post-marketing + Strong experience in Good Clinical and Good Pharmacovigilance Practices and knowledge of evolving regulations, such as ICH E6 R3 ... Proven experience advising business functions in the biopharma industry on quality and compliance requirements and continuous improvement + Experience working across… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data Sheets (CCDS) ... with Global Labeling Operations and Compliance Leads to produce high quality labeling documentation. + Establishes Processes and Best Practices: Reinforces labeling… more
- AbbVie (South San Francisco, CA)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Medical Director leads the direction, planning, execution, and interpretation of clinical ... and may lead cross-functional teams to generate, deliver, and disseminate high- quality clinical data supporting overall product scientific and business strategy.… more
- AbbVie (North Chicago, IL)
- …Participates in cross-functional teams to generate, deliver and interpret high- quality clinical data supporting overall product scientific and business strategy. ... and responses and other program documents. + May oversee the work of Associate Medical and/or Scientific Directors and of Clinical Scientists working on the same… more
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