Associate Director, Clinical & Regulatory Writer
ProKatchers LLC
ProKatchers LLC in Gaithersburg, MD invites an Associate Director, Clinical/Regulatory Writer to lead regulatory documentation in drug development. You will author CSPs, CSRs, IBs, Clinical Overviews, and Summary documents, interfacing with clinical, regulatory, and quality teams. The ideal candidate has 5–15 years of pharmaceutical regulatory writing experience, a Master's in Life Sciences (PhD preferred), and a track record coordinating cross‑functional teams through submissions to FDA/EMEA. #J-18808-Ljbffr ProKatchers LLC
$136.78k - $205.18k
...We are now recruiting an Associate Director, R&I Clinical Regulatory Writing (CReW). As part of a clinical delivery or submission team, the Associate... ...teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality. ~ Drive...SuggestedHourly payContract workTemporary work$133.04k - $199.56k
...Clinical Regulatory Writer, Associate Director / Manager Location: Boston, MA OR Gaithersburg, MD- Hybrid (3 days onsite) Introduction to role: Are you ready to be part of the solution, turning drug development strategies into reality? As an Associate Director in...SuggestedHourly payTemporary workWork at officeFlexible hours3 days per week- AstraZeneca is seeking an Associate Director/Manager in Clinical Regulatory Writing in Gaithersburg, MD, with a hybrid work arrangement (3 days onsite). The role leads complex regulatory writing efforts across drug projects, ensuring regulatory and quality standards. You...Suggested
- ...Precigen is seeking a highly motivated and experienced Associate Director/Senior Manager, Regulatory Affairs(level based on candidate experience). This... ...aspects of Precigen's quality, CMC, preclinical, and clinical drug development programs, policies, and procedures ensuring...SuggestedWork at office
$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion... ...approval activities in local region(s).Experience with clinical trial and licensing requirements in all major countries in...SuggestedFull timeLocal area$151.23k - $226.84k
...and connect on key projects. An Associate Director in the Quantitative COA Science team,... ...Excellence, will have experience in the use of clinical outcomes assessments (COA) such as... ...and external requirements, including regulatory or compliance standards.- Provide...Hourly payTemporary workWork at office3 days per week- Job Title : Associate Director, Clinical/ Regulatory Writer Location : Gaithersburg, MD 20878 Duration : 12 Months Education : Master's Degree in a life science Job Description : We're seeking an experienced Regulatory Writer/Medical Writer with hands‑on pharmaceutical...
- The Clinical Regulatory Writing team provides expert communications leadership to drug projects... .... The Clinical Regulatory Writing Associate Director is expected to: Independently manage... ...strong partnership with vendor medical writers to ensure delivery to time and quality...
- A clinical-stage biopharmaceutical company is seeking an Associate Director, Bioinformatics in Rockville, Maryland. This role involves providing technical leadership for clinical development programs, managing a team, and ensuring high-quality data generation and analysis...
$142.5k - $256.5k
...radically changing the biotech industry.Reporting to the Director, Regulatory Information Management (RIM), the Associate Director, Regulatory Data Management &... ...#LI-NH1-SummaryLocation: Cambridge, Massachusetts; Clinical Development; Bethesda, MarylandType: Full timePermanent employmentFull timeFor contractorsWork at officeWork from home$110k - $125k
...Chemistry is seeking a talented and dynamic Associate Medical Director to join our growing Medical Affairs... ...client objectives. Analyze complex clinical and scientific data to generate clear... ...leadership and mentorship to medical writers, fostering a culture of excellence...Work experience placementWork at officeLocal areaRemote workShift work- ...Associate Director, Cell Therapy Trade Compliance Operations Introduction to role: At... ...Operations, Global Supply Chain, Quality, Regulatory, and Digital teams to ensure cross-... ...equivalent. Experience supporting clinical-to-commercial transition, global expansion...Hourly payTemporary workWork at officeFlexible hours3 days per week
$150.1k - $225.15k
...Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to...Full timeTemporary workWork at officeFlexible hours3 days per week$110k - $125k
A global healthcare agency is seeking a talented Associate Medical Director to lead the development of high-impact medical content. This role involves leveraging medical writing and scientific storytelling to enhance healthcare provider education and patient outcomes....Remote job- Experis, part of ManpowerGroup, is seeking an Associate Director of Clinical Operations to join a leading pharmaceutical/biotech organization. The role supports multiple therapeutic areas within Clinical Operations and requires strong leadership and strategic thinking....Remote job
- What You Will DoA leadership role combining clinical, scientific, commercial, and operational expertise to drive the successful development... ...scientific rigor and commercial goals, ensuring products meet regulatory, market, and patient needs throughout their lifecycle. • Plan,...Full timeLocal areaWorldwide
$140k - $175k
Our client, a leading pharmaceutical/biotechnology organization, seeks an Associate Director of Clinical Operations to oversee trial management, site monitoring, and regulatory compliance in a remote role. Requires 10+ years in pharma/biotech with regulatory/clinical ops...Remote job$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week$218.06k - $327.09k
Job Title: Senior Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg... ...aligning regulatory objectives with clinical, CMC, safety and commercial strategies... ...maintenance and compliance activities associated with marketed brands, ensuring...Hourly payFull timeTemporary workStart working todayWork at officeFlexible hours3 days per week$276k - $414k
Job Title: Executive Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to set the global regulatory direction for first-in-class cell therapies...Hourly payFull timeTemporary workWork at officeWorldwideFlexible hours3 days per week- ...About the role: Accompany Health Med-Psych Associate Medical Directors (AMDs) are key clinical leaders supporting patients and care teams across our Standard and Complex Care models. You will work with health advocates, physicians, nurses, behavioral health clinicians...
- ...Dow Jones in Gaithersburg, MD, seeks a Research and Analysis Associate Director to lead data research, normalize data from our software customer base, and ensure accuracy within the Customer Support group. The role emphasizes analytical prowess, Excel and SQL proficiency...
$169.22k - $253k
...Associate Director, Biostatistician Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy... ...expertise/input in drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical...Temporary workLocal areaRemote workWorldwide- Job Opportunity At TFC Consulting, Inc. TFC Consulting, Inc. is a CPA firm in Rockville, MD. We help the federal government address financial management and compliance challenges. We are actively seeking individuals with experience in federal financial management (including...Contract workWork at office
- ...immunotherapies to patients. We have multiple products being evaluated in the clinic using our innovative manufacturing approach to cell and gene therapies.We are seeking a global Executive Director, Regulatory Affairs (level determined by candidate experience)reporting into the...
$151.23k
...world evidence into decisions that transform cancer care?As Associate Director, Oncology Outcomes Research, you will lead high‑impact health... ...to shape strategy and deliver evidence that influences clinical practice and payer decisions.This is an opportunity to work...Full timeTemporary workWork at officeFlexible hoursShift work3 days per week- Stryker Corporation in Bethesda, Maryland is seeking a Med-Psych Associate Medical Director to lead integrated behavioral health services. In this role, you will supervise Med-Psych and Psych APCs, provide psychiatric care, and collaborate with a multi-disciplinary team...
$208.06k - $262.15k
.... USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-... ..., post-market surveillance systems, and clinical study capacity for Bioequivalence/Bioavailability... ..., the followingdirect reports:Director / Sr Manager, International regulatory and...Full timeWork experience placementWork at officeWorldwide- AstraZeneca is seeking an Associate Director for Cell Therapy Sourcing & Procurement to develop and deploy global category strategies, lead major supplier relationships, and partner with stakeholders to ensure value delivery. This role has a global remit and involves driving...
- The Medical Writer collaborates with members of cross-functional teams to prepare... ..., investigator brochures, synopses, regulatory documents, clinical publications, and related clinical... ...the medical writing responsibilities associated with multiple studies at various...
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