Senior Director: Regulatory & Medical Writing Leader
BioSpace
Nurix Therapeutics is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the medical writing group and shape the strategy for key regulatory documents. You will guide internal and contract writers, ensure timely and high-quality deliverables, and collaborate with Clinical Science and Regulatory teams across oncology programs. The role requires extensive experience directing regulatory writing for major submissions (NDA, BLA, MAA), a deep understanding of GCP/ICH and FDA #J-18808-Ljbffr BioSpace
$245k - $285k
...responsible for leading and managing the regulatory affairs within CMC function. This... ...addition, the position assists corporate senior management in understanding CMC Regulatory... ...submission needs. Track and report on Medical Writing and Regulatory Operations projects, timelines...SeniorMedicalContract work$254.13k - $289.39k
...at the forefront of patient care, writing medicine’s next chapter with a new... ...Development Team responsible for providing regulatory writing expertise and leadership to... ...documents for submission. The Sr. Director, Head of Regulatory & Medical Writing will be responsible for...SeniorMedicalOdd jobFor contractorsFlexible hoursShift work- Enigma Search is looking for an Associate Director, Medical Writing, to oversee the development of clinical and regulatory documentation. The ideal candidate will have an advanced degree in life sciences and over 8 years of medical writing experience in biotech or pharmaceutical...SeniorMedical
$265k - $285k
...comResponsibilities include: Provides regulatory leadership in support of the... ..., Clinical Operations, Medical Affairs, CMC, and Quality to... ...ability to influence senior leadership and cross-functional... ...requirementExcellent regulatory writing and review skills with demonstrated...SeniorMedical- Enigma Search is looking for an Associate Director, Medical Writing in South San Francisco, California. This role involves leading the development of clinical and regulatory documentation, ensuring compliance with global standards, and managing the writing process. The...Medical
$186k - $235k
Structure Therapeutics in South San Francisco seeks an Associate Director of Medical Writing. The role includes leading the development of regulatory documents and performing quality control reviews to ensure compliance. The ideal candidate will have over 5 years of experience...SeniorMedical$143k - $175k
...structure, visibility, and execution discipline to a growing Regulatory function at Maze. At Maze,we’reon a mission to uncover... ...that regulatory activities, health authority interactions, medical writing timelines, and submission-related workstreams are organized...SeniorMedical- Veratherapeuticsinc seeks a Senior Manager, Regulatory CMC to manage regulatory submissions and activities within a dynamic team. This role requires... ...0 to $214,000, performance bonuses, equity options, and comprehensive medical benefits. #J-18808-Ljbffr VeratherapeuticsincSeniorMedical
$244k - $305k
...signaling pathway. The Opportunity: The Senior Director, Molecule Global Regulatory Lead will develop and execute... ...and lifecycle management. This leader will shape innovative and... ...closely with Regulatory Operations, Medical Writing, Clinical Development, Biometrics...SeniorMedicalFull timeLocal area$258k - $320k
...Primary Function: Responsible for leading the global CMC regulatory strategy and execution for both small molecule and biological... ...units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility...SeniorMedicalFull timeWorldwideRelocation package- ...Reporting to the Chief Technical Officer, we are hiring a Director, CMC Regulatory Affairs to join our Technical Operations team. This role leads... ...additional experience). Excellent CMC technical writing and communication skills with a strong background in small...Senior
- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across clinical programs, ensuring documents are... ...consistent, and submission-ready. Reporting to the VP of Regulatory and Quality Science, you will partner with Regulatory...Medical
- Rigel Pharmaceuticals, Inc. is seeking an Associate Director, Drug Safety Physician to lead medical review and safety signal detection for its oncology... ...pharmacovigilance expertise, leadership experience, and global regulatory knowledge to guide safety decisions across trials...SeniorMedical
- Maze Therapeutics is seeking a senior regulatory medical writer to lead the function across development programs. You will develop high-quality clinical and regulatory documents and manage external vendors to ensure timely, compliant deliverables. You will partner with...Medical
- Maze Therapeutics is seeking a Director of Medical Writing to lead the medical writing function across development programs, ensuring accuracy... ...consistency, and submission-readiness. Reporting to the VP of Regulatory and Quality Science, you will manage internal teams and...Medical
- Nurix Therapeutics, Inc. is seeking a Sr. Director, Head of Regulatory & Medical Writing to lead the regulatory writing group and guide the preparation of high-quality regulatory documents for clinical trials and submissions. You will collaborate with Clinical Science,...Medical
$172.5k - $260.1k
...model; this is essential, not a nice-to-have.You're comfortable writing SQL against Snowflake-backed sources to validate what a... ...of benefits to help you live well including: time off programs, medical, dental, vision, mental health support, paid parental leave, life...SeniorMedicalFull time$245k - $302k
Initial Therapeutics, Inc. is seeking a Senior Director of Medical Writing in South San Francisco. The ideal candidate will provide leadership on regulatory documents and oversee a team, requiring an extensive background in oncology and successful IND submissions. Competitive...Medical$337.5k - $412.5k
Maze Therapeutics in South San Francisco is looking for a Senior Medical Director to lead clinical development programs focused on innovative treatments. This role requires 6+ years of drug development experience and expertise in clinical trial design. The Senior Medical...SeniorMedical- Kardigan in South San Francisco, CA is seeking an experienced Medical Science Liaison to advance the cardiovascular medical strategy in a defined territory. The MSL acts as scientific leader in heart failure, cardiomyopathies, hypertension, and related areas, building...SeniorMedical
- Kardigan is seeking a Medical Science Liaison (MSL) to lead field-based scientific engagement in cardiovascular disease. You will build trusted partnerships with cardiologists and researchers and implement our medical strategy locally. The role requires 3+ years in cardiovascular...SeniorMedical
$201k - $272k
...world's most adopted cloudAs a leader in the Customer Solutions... ...as well as develop speaking, writing, presentation, and executive interaction... ...strong relationships with senior stakeholders internal and... ...benefits including health insurance (medical, dental, vision, prescription,...SeniorMedicalLocal areaWorldwideFlexible hours- ...Associate Director, Regulatory Affairs The Associate Director, Regulatory Affairs supports... ...regions. This role works closely with senior regulatory leadership to develop recommendations... ...Clinical, Nonclinical, Biometrics, Medical Writing, CMC, and other functions. Partner...MedicalWork at office
- ...BEPC Inc. is seeking a Senior Medical Content Writer, Claims to join our client’s site in South San Francisco, CA. The role focuses on developing... ...promotional and educational claims; ensuring accuracy and regulatory alignment for MLR review. The position works within an in-...SeniorMedical
- ...health issues today and address the medical challenges of tomorrow. We strive to... ...Instagram,XandYouTube. Job Description The Senior Manager Regulatory Affairs, Global Reg Strategy US &... ...Regulatory Lead (GRL), Associate Director, or Director), in the development & execution...SeniorMedical
$162.5k - $301.7k
Senior Thought Leader Liaison (TLL) - Neuroimmunology We’re passionate about delivering on Our Promise to improve the lives of patients and create... ...to shape TA/brand strategy, collaborating with Marketing, Medical, Global and CE partners. Participate actively in core...SeniorMedicalLocal areaRelocation packageShift work$218.06k - $327.09k
...Job Description The Senior Director, Oncology Cell and Gene Therapy Regulatory Affairs, leads the development and implementation... .... They are viewed as a Senior Leader within the Regulatory Community.... ...and, health benefits including medical, prescription drug, dental, and...SeniorMedicalHourly payTemporary workWorldwideFlexible hours3 days per week- ...Pharmaceuticals Inc. in South San Francisco, CA is hiring a Director, CMC Regulatory Affairs to lead regulatory strategies for CMC across... ...prepare global submissions. The role requires strong scientific writing, experience with INDs/NDA/MAA filings, and deep knowledge of...
- Job DescriptionWe are seeking an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group responsible for... ...applications. This individual will partner with various research and regulatory functions to prepare high-quality scientific and regulatory...SeniorMedicalFull time
$175k - $205k
...cancer. Position Summary Reporting to the Executive Director, CMC Regulatory Affairs, the Senior Manager or Associate Director of CMC Regulatory Affairs... ...that includes: Paid Time Off, Holiday, and Sick Leave, Medical, Dental and Vision Plans, Short- and Long-Term...SeniorMedicalTemporary workCasual workLocal areaWorldwideFlexible hours
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