External Comms Associate Director
The Fountain Group
External Comms Associate Director/Clinical Regulatory Writing Associate Director Location: Gaithersburg, MD — Onsite/Hybrid as applicable Pay Rate: $76/hr. W2 Duration: 12 Months Shift: Day, 8:00 AM-4:00 PM or 9:00 AM-5:00 PM Interview Process: 30-minute Teams interview followed by a 2-hour Teams panel interview Job Description Lead clinical regulatory writing activities across complex portfolios. Author and review complex clinical-regulatory and submission documents. Develop Clinical Submission Communication Strategies (cSCS). Lead internal and external medical writing teams and vendor writers. Interpret complex clinical data and translate findings into concise regulatory messaging. Support drug development programs from development through launch and lifecycle management. Drive regulatory writing quality, process improvements, and operational excellence. Provide strategic writing and communications leadership at the program level. Education Master's degree in Life Sciences or an appropriate scientific discipline required. Ph.D. or other advanced scientific degree preferred. Required Skills Significant clinical/medical writing experience within the pharmaceutical industry or CRO environment. Clinical regulatory writing and submission document experience. Expertise in clinical-regulatory document development and review. Strong understanding of drug development processes and lifecycle management. Knowledge of pharmaceutical regulatory requirements and submission standards. Experience developing clinical Submission Communication Strategies (cSCS). Experience interpreting complex clinical data for regulatory documents. Experience leading medical writing activities across clinical development programs. Experience managing internal, external, and vendor medical writers. Expertise in label-focused clinical-regulatory communications. Preferred Skills Ph.D. in a scientific discipline. Experience supporting complex global pharmaceutical submissions. Experience establishing clinical regulatory writing standards and best practices. Experience leading strategic communication activities across multiple drug development programs. Experience driving clinical regulatory writing process optimization and operational excellence. #J-18808-Ljbffr The Fountain Group
$115k - $173k
...The Associate Director, External Operations, Cell Therapy – External Supply Management , leads external manufacturing partner operations. These operations span a network of CDMOs and external partners supporting cell therapy across autologous, allogeneic, in vivo, and...SuggestedFull timeContract workTemporary workAstraZeneca
Gaithersburg, MD5 days ago$151.23k
...world evidence into decisions that transform cancer care?As Associate Director, Oncology Outcomes Research, you will lead high‑impact health... ...of peer‑reviewed manuscripts; shape internal and external narratives with clear, evidence‑based insights.Governance and...SuggestedFull timeTemporary workWork at officeFlexible hoursShift work3 days per week$160k - $215k
...their families, and to their communities.The opportunityAs the Associate Director, Rare Disease Product Marketing, you’ll serve as an insights... ...implications.Experience managing agencies, vendors, and external partners to deliver high-quality marketing and insights work...SuggestedFull timeWork experience placementSummer work$170k - $198k
...making a real impact on patient outcomes. Job Summary The Associate Director, Access Reimbursement Management will provide education, assistance... ...and communicate effectively to internal stakeholders and external HCPs regarding education on Medicaid (FFS and Managed Care),...SuggestedWork at officeRelocationVisa sponsorship- Overview Kolon TissueGene, Inc. is seeking an Associate Director, Bioinformatics to provide hands-on technical and operational leadership supporting... ...with Clinical Operations, Medical Affairs, Regulatory, and external partners to align data strategies with organizational and...Suggested
$169.22k - $253k
...The Associate Director of Real‑World Data Science is an expert in analysis and methods, providing leadership within Otsuka's OPDC, reporting... ...questions and align with therapeutic area strategy. External Partnerships: Participate in establishing external partnerships...Temporary workFor contractorsFlexible hoursOtsuka
Rockville, MD1 day ago$146.3k - $234.1k
...About the Role: As the Associate Director AS&T Lifecycle Management, you will be making a meaningful contribution to the ongoing product... ...projects cross-functionally with CMC team members and external partners • Evaluation and review of technical and regulatory...WorldwideBiontech
Gaithersburg, MDa month ago$151.23k - $226.84k
...strategize, brainstorm and connect on key projects. An Associate Director in the Quantitative COA Science team, Centre of Excellence,... ...internal stakeholders (e.g., Study teams, Strategy, Product) and external stakeholders, e.g., Global and Clinical Study Teams, and...Hourly payTemporary workWork at office3 days per weekGaithersburg, MD5 days ago$147.02k - $220.53k
...outcomes for consumers, healthcare providers, and patients? As Associate Director, Capabilities and Partnerships, you will serve as the... ...Identify gaps in data and analytics; source or engage internal and external capabilities and vendors to integrate data and build the...Hourly payTemporary workWork experience placementWork at officeShift work3 days per weekGaithersburg, MD5 days ago$116.6k - $177.8k
POSITION SUMMARY:The Associate Director, Bioanalytical Client Services serves as the liaison between the Strategic Sales team and the Bioanalytical... ...processes and activities.• Facilitate discussions between external customers and internal groups as needed.• Generate non-...Full timeContract workTemporary workWork at officeFlexible hours$131.6k - $205.7k
...guideline as MSD considers other factors when presenting an offer of employment, such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities, education and experience. Employees may qualify for a...Temporary workWork at officeFlexible hours$131.6k - $205.7k
POSITION SUMMARY The Associate Director, Technical Writing will lead our technical writing team. This role is responsible for producing high... ..., such as scope and responsibilities of the position, external market factors, and the candidate's knowledge, skills, abilities...Temporary workWork at officeRemote workFlexible hours- The Associate Director / Lead Engineer leads a small team of software engineers responsible for designing and delivering the data pipelines... ...Technology, and maintain them over time.Establish and maintain external relationships with strategic product/service vendors and...Full timeTemporary workFor contractorsWork experience placementFor subcontractorLocal areaImmediate start
$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... ...Submission Communication Strategy. ~ Lead internal/external authoring teams and provide strong partnership with vendor medical...Hourly payContract workTemporary workGaithersburg, MD2 days ago- Associate Director of Cyber Security - IT Operations 5 Days a week onsite We’re looking for an experienced Associate Director of Cyber Security... ...architecture across global IT infrastructure. Manage external SOC provider and internal cyber engineer. Lead incident response...
$157k - $186k
...making a real impact on patient outcomes. Job Summary: The Associate Director, Drug Safety and Medical Monitoring is responsible for... ...accuracy, completeness, and consistency prior to internal and external submissions; collaborate closely with Clinical, Regulatory,...Full timeContract workWorldwideVisa sponsorshipSupernus Pharmaceuticals, Inc.
Rockville, MDa month ago- ...philanthropic guidance, strategic giving, and stewardship. The Associate Director, Foundation Communications serves as the Foundation's... ...efforts ~ Build strong relationships with internal and external stakeholders to ensure communications are coordinated, timely...Relocation3 days per week
The Jewish Federation of Greater Washington
Rockville, MD5 days ago - Reporting to the Head of US Marketing, the Associate Director, Indication Marketing Lead, US is responsible is responsible for developing and... ...execution Intermediate skills to network internally and externally Advanced ability to draw insight from market research, the...
$175k - $205k
Job Summary:We are seeking an entrepreneurial, high-autonomy Associate Director of Communications & Public Relations to serve as the strategic architect and hands-on leader of our external and internal messaging.This isn't a "maintenance" role. We are looking for a builder...Full timeTemporary workWork experience placementImmediate startFlexible hours- ...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...
News Corp
Gaithersburg, MD10 hours ago - ...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...
ProKatchers
Gaithersburg, MD10 hours ago - ...Associate Director, Cell Therapy Trade Compliance Operations AstraZeneca Gaithersburg, Maryland, United States Full-time Introduction To Role AtAstraZeneca Cell Therapy, we are building the capabilities required to deliver complex, personalized therapies through a highly...Hourly payFull timeTemporary workWork at officeFlexible hours3 days per week
Compliance Officer Jobs
Gaithersburg, MD17 hours ago $169.22k - $253k
...Associate Director, Biostatistician Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products...Temporary workLocal areaRemote workWorldwideOtsuka Pharmaceutical
Rockville, MD1 day ago- ...implementation of agreed processes, technologies, and best practices. • Lead the selection and negotiation processes for CROs and external partners, ensuring timely, quality delivery to specified standards. • Participate in steering committees, regulatory defense teams...Full timeLocal areaWorldwide
- 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
TFC Consulting
Rockville, MD4 days ago $87.33k - $108.4k
...collaborative work environment. Brief Job Overview The External Engagement Associate supports the execution of external engagement, communications... ...facing activities. Working under the supervision of the Director, External Engagement, the Associate contributes to...Full timeWork at officeWorldwide- The Associate Director / Lead Engineer leads a small team of software engineers responsible for designing and delivering the data pipelines... ...Technology, and maintain them over time. Establish and maintain external relationships with strategic product/service vendors and...
$110k - $125k
...biotech industries. Discover your purpose. Embrace innovation. Experience . Real Chemistry is seeking a talented and dynamic Associate Medical Director to join our growing Medical Affairs team. This role is an excellent opportunity to lead the development of cutting‑edge,...Work experience placementWork at officeLocal areaRemote workShift workReal Chemistry
Gaithersburg, MD2 days ago$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 people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to...Full timeLocal area- ...submissions and approvals. The Clinical Regulatory Writing Associate Director is expected to: Independently manage clinical regulatory writing... ...Submission Communication Strategy (cSCS). Lead internal/external authoring teams and provide strong partnership with vendor medical...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to External Comms Associate Director. Be the first to apply!
- associate manager Gaithersburg, MD
- associate director clinical operations Gaithersburg, MD
- associate director Gaithersburg, MD
- associate scientific director Gaithersburg, MD
- remote associate product manager Gaithersburg, MD
- associate director clinical research Gaithersburg, MD
- associate artistic director
- freelance associate creative director
- associate director supply chain
- associate manager