Clinical Regulatory Writing Associate Director
Zenith LifeScience
The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies, regulatory requirements, and communications best-practices. We support the Company’s core therapeutic areas in all phases of clinical development. Our vision is to be an industry leading organization driving strategic communication excellence to achieve successful submissions and approvals.
The Clinical Regulatory Writing Associate Director is expected to:
- Independently manage clinical regulatory writing activities across a complex portfolio of work.
- Author the most complex clinical-regulatory documents within a program by ensuring that relevant regulatory, technical and quality standards are achieved, and that relevant processes and best practice are applied.
- As part of a clinical delivery or submission team, provide strategic communications leadership to projects, establish communication standards and best practice, and continuously advocate for quality and efficiency.
- When acting as a submission lead, drive the development of the clinical Submission Communication Strategy (cSCS).
- Lead internal/external authoring teams and provide strong partnership with vendor medical writers to ensure delivery to time and quality.
- Drive the clinical interpretation of complex data and information and condense it into clear, concise and accurate messages that address customer information requirements.
- Be a strategic thinker and demonstrate strategic review capabilities.
- Proactively collaborative with other functions at the program level.
- Support the development of Clinical Regulatory Writing Managers.
- Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the skill on drug and non-drug projects, as required
Education, Qualifications, Skills and Experience
Essential:
- Life Sciences masters degree in an appropriate discipline.
- Significant medical writing experience in the pharmaceutical industry or CRO.
- Ability to advise and lead communication projects.
- Understand drug development and communication process from development, launch through life cycle management.
- In depth knowledge of the technical and regulatory requirements related to the role
Desirable: Advanced degree in a scientific discipline (Ph.D.).
Vacancy posted 3 hours ago
Similar jobs that could be interesting for youBased on the Clinical Regulatory Writing Associate Director in Gaithersburg, MD vacancy
- ...Job Title: Associate Director Clinical Regulatory Writing Location: Gaithersburg, MD – 20878 Duration: 12 Months Job Description: Independently manage clinical regulatory writing activities across a complex portfolio of work. Author the most complex clinical...Suggested
ProKatchers LLC
Gaithersburg, MD3 hours ago $133.04k - $199.56k
...Job Title: Clinical Regulatory Writer, Associate Director / Manager Location: Gaithesrburg, MD- Hybrid (3 days onsite) Introduction to role: Are... ...reality? As an Associate Director in Clinical Regulatory Writing, you'll play a pivotal role in translating life-...SuggestedHourly payTemporary workWork at officeFlexible hours3 days per week$137k - $235.75k
...best talent for the role of Associate Director, Oncology Epidemiology .... ...and study conduct across the clinical development program. May... ...with the FDA and other Regulatory Agencies regarding regulatory... ...methods. Experience with writing observational study...SuggestedFull timeTemporary workLocal areaRemote workJohnson & Johnson
Gaithersburg, MD2 days ago$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 Director provides strategic communications leadership to projects, establishes communication standards and best practice...SuggestedHourly payContract workTemporary work$118.07k - $177.11k
...Audit readiness support for regulatory inspections queries related... ...knowledge of CFRs, EuDRA and associated guidances, regulations and annexes... ...of CGT products for clinical use in humans. Desired... ...Degree. Experience writing and reviewing SOPs and other...SuggestedHourly payContract workTemporary workAstraZeneca
Gaithersburg, MD1 day ago- EmergencyMD in Gaithersburg, MD is looking for an Associate Director, R&D Finance. This critical role involves leading finance for MASH Phase... .... Candidates should have over five years of experience in clinical R&D finance within a public biopharma setting, along with a...
- ...analysis and value and scientific evidence generation to support clinical, economic, and patient-centered value propositions and... ...knowledge of epidemiology, economics, psychometrics, and medical writing.- **Project Management:** Proven ability to manage complex projects...For contractors
$150k - $190k
...visionary and operationally astute Associate Director of Artificial Intelligence,... ...science and life-saving clinical research. Sitting at... ...Proposal Authorship: Personally write key sections of technical... ...valued at $15M+. ~ Regulatory Experience: Proven track record...Local areaImmediate startFlexible hoursAxle
Rockville, MD5 days ago$115.92k - $173.88k
...Associate Director, Cell Therapy Logistics Process At AstraZeneca, we put patients first and... ...improvement that enable scalability from clinical to commercial, cost reduction, and... ...with Clinical Supply, Manufacturing, QA, Regulatory, and external partners to align...Hourly payTemporary workWork at officeWorldwide3 days per weekAstraZeneca
Gaithersburg, MD10 days ago$500 per month
...Job Description Job Description Description : The Clinical Regulatory Writing team provides expert communications leadership to drug projects and authors strategically important clinical-regulatory documents that are label focused and align with project strategies...Permanent employmentFull timeContract workWork at office- The Associate Director, Product Management leads a product team (typically 2-3) responsible for a specific product or set of products. This... ...experience in product and/or experience management Strong writing ability Strong business acumen Experience with Agile software...Work experience placementLocal area
$151.23k - $198.49k
...potential of digital health, transforming how clinical research is conducted, how care is... .... About the Opportunity: As an Associate Director Scientist within Evinova Quantitative... ...reports, presentations, publications, and regulatory materials Integrate AI-enabled analytics...Full timeTemporary workWork at officeWorldwide3 days per week$64.2k - $109.2k
Regulatory Affairs Specialist - Murtha Cancer Center Research Program... ...Assists in protocol writing, obtaining the required institutional... ...errors, ensuring that Good Clinical Practices (GCP) are adhered... ...regulatory. Performs tasks associated with the institutional...For contractorsWork at officeLocal area- ...of experience in product and/or experience management* Strong writing ability* Strong business acumen* Experience with Agile software... ...keeping the markets fair and proactively addressing emerging regulatory issues before they harm investors or the markets. FINRA operates...Work experience placementWork at office
- Altimmune (NASDAQ: ALT) is a late-stage clinical biopharmaceutical company focused on developing innovative peptide-based therapeutics... ..., please visit Candidate Summary Altimmune is seeking an Associate Director, R&D Finance, to serve as the primary finance lead for the...Contract work
$164.53k - $245.99k
...products for the maintenance of everyday health. As an Associate Director, Biostatistician, you will be a champion of Otsuka’s... ...expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and...Temporary workInterim roleLocal areaRemote workWorldwideFlexible hours- ...prominent healthcare organization in Maryland is seeking an experienced physician leader for the Associate Chair of Oncology Services role. This position involves providing clinical oversight, developing cancer care programs, and expanding the Hematology and Medical...
$143.62k - $215.43k
Job Title: Director Occupational Toxicology Introduction to Role Are you ready to lead the... ...limits and author documentation for regulatory compliance, including Permitted Daily Exposures... ...Proven proficiency in technical science writing, specifically in regard to chemical...Hourly payTemporary workWork at officeFlexible hours3 days per week$169.95k - $283.25k
SERM Scientific Director At GSK, we have bold ambitions for patients... ...of key GSK assets or in clinical development and/or the post‑marketing... ...safety component of global regulatory submissions. Perform expert... ...Communicate verbally and in writing and influence internally and...Local areaWorldwide- ...Act responsibly Job Overview The Medical Director is a therapeutic and disease area expert... ...addition, the Medical Director supports clinical research, internal training,... ...experience (strongly preferred). Experience writing scientific publications, posters, and manuscripts...
- ...Global Marketing Associate Director, Breast Cancer At AstraZeneca, we turn ideas into life-changing medicines. Working here means being entrepreneurial, thinking big, and working together to make the impossible a reality. We're focused on the potential of science to...Hourly payTemporary work
AstraZeneca
Gaithersburg, MD1 day ago - ...is a dedicated discovery and clinical stage biopharmaceutical company... ...our efforts we are seeking a Director, Medical Affairs will be... ...the clinical development and regulatory teams. The Director, Medical... ...and clinical development in writing target product profiles, forecasting...
Precigen, Inc
Germantown, MD20 days ago - 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, MD5 days ago - ...Hands-on experience working knowledge of security frameworks and regulatory requirements such as NIST SP 800-171, CIS Controls, FERPA,... ...remediation efforts simultaneously. *) Hands-on experience in writing policies, standards, processes and procedures. *) Hands-on...Work experience placement
Dataman Ltd
Rockville, MD4 days ago $151k - $227k
...Statistical Science Associate Director Location: Gaithersburg The Statistical Science... ...• For a project or indication in clinical therapeutic areas • Leading the delivery... ...delivery of studies, development plans, regulatory strategy, health technology assessment...Temporary work- A leading pharmaceutical company in Rockville is seeking a Health Economics and Outcomes Research Specialist. The role involves strategic leadership in health economics research, collaboration with various teams, and rigorous data analysis. Candidates should have a PhD ...
$1,800 per month
The Associate Director of Donor Engagement, Women’s Philanthropy is a relationship builder who works with donors and lay leaders (volunteers) to advance Federation’s mission and vision through the work of Financial Resource Development (FRD). This role is central to identifying...- The Jewish Federations of North America seeks an Associate Director of Donor Engagement, Women’s Philanthropy in Rockville, Maryland. This pivotal role focuses on building relationships with donors and lay leaders to enhance Federation's fundraising efforts, particularly...
- Associate Director, Knowledge Management, OCLO page is loaded## Associate Director, Knowledge Management, OCLOlocations: Washington, DC (Job... ...and relevant information to staff across FINRA relating to regulatory policy. This role works with a high level of autonomy and discretion...Full timeTemporary workWork experience placementWork at officeLocal areaImmediate start
- Cheez is a new app that sends you the pictures that your friends take of you, powered by facial recognition. See the iOS app or the Android app Responsibilities: Assist in defining product requirements, objectives, and key results based on user needs and market...Full time
Cheez
Gaithersburg, MD2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Regulatory Writing Associate Director. Be the first to apply!
Related searches
- medical office assistant work from home Gaithersburg, MD
- healthcare consulting manager Gaithersburg, MD
- hospital supervisor Gaithersburg, MD
- healthcare supervisor Gaithersburg, MD
- senior manager clinical operations Gaithersburg, MD
- health services director Gaithersburg, MD
- occupational health manager Gaithersburg, MD
- medical director neurology Gaithersburg, MD
- medical director oncology Gaithersburg, MD
- medical coding supervisor Gaithersburg, MD