Jobs / United States / Astrazeneca Pharmaceuticals Lp
Associate Director, R&I Clinical Regulatory Writing (CReW)
Astrazeneca Pharmaceuticals Lp · 🇺🇸 US - Gaithersburg - MD
Sponsorship verdict
Sponsorship possible
One solid signal, not two — worth applying, and worth asking about sponsorship early.
- Employer is on a government sponsor recordThe US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
- The posting doesn’t mention sponsorshipSilence isn’t a refusal — ask the recruiter before investing much time.
- No salary bar for this routeH-1B has no fixed salary bar: the employer must pay at least the prevailing wage for the role and area. Cap-subject employers enter a lottery weighted by wage level. Source: https://www.federalregister.gov/documents/2025/12/29/2025-23853/weighted-selection-process-for-registrants-and-petitioners-seeking-to-file-cap-subject-h-1b, rules effective 2026-02-27.
- What Astrazeneca Pharmaceuticals Lp paid sponsored hires in similar roles15 certified filings for “Associate Director Oncology Outcomes Research” (Medical Scientists, Except Epidemiologists) in MD: $126k–$185k, median $140k. Most were filed at wage level II (47%) — 2 lottery entries, ≈31% projected selection odds for cap-subject employers. Source: US Department of Labor LCA disclosure data (Oct 2025 – Jun 2026).
- Confirmed live todayWhen a source last listed this job as open.
US H-1B: cap-subject employers enter a lottery weighted by wage level — Level I gets 1 entry, Level IV gets 4 (DHS projected selection odds ≈15% at Level I to ≈61% at Level IV). Universities and non-profit research employers are cap-exempt. The $100,000 fee for new petitions from abroad is currently blocked by a court order (appeal pending).
A verdict summarises public evidence; it is not legal advice and never a guarantee — the employer and the immigration authority decide. Sign in to factor in where you can already work.
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Sponsor Radar — Astrazeneca Pharmaceuticals Lp
The US Department of Labor certified 99 H-1B/E-3 labor condition applications for this employer between Oct 2025 and Jun 2026 (latest Jun 2026) — the step every H-1B hire needs first. USCIS also records 31 H-1B approvals in FY2023. Source: LCA disclosure data (US Department of Labor (OFLC)).
Past sponsorship or register membership never guarantees sponsorship for this vacancy or for you. Full Sponsor Radar for Astrazeneca Pharmaceuticals Lp →
About the role
We are now recruiting a n Associate Director , R&I Clinical Regulatory Writing ( CReW ) . A s part of a clinical delivery or submission team, the Associate Director provide s strategic communications leadership to projects, establish es communication standards and best practice, and continuously advocate s for quality and efficiency. The Associate Director also a uthor s strategic clinical-regulatory documents and provid es critical review to achieve high-quality standards, utilizing best practices for document and accelerated submission delivery . What You will Do The Associate Director, CReW , is expected to: • Independently manage clinical regulatory writing activities across a portfolio of work. • Author 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. • D rive the development of the clinical Submission Communication Strategy. • 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 information requirements. • Be a strategic thinker and demonstrate strategic review capabilities. • Proactively collaborative with other functions at the program level. • Support the development of others in Clinical Regulatory Writing. • Drive continuous improvement and operational excellence from a communications leadership perspective, including representing the Clinical Regulatory Writing function on drug and non-drug projects, as required . Minimum Qualifications: • A Bachelor's degree • At least 5 years of e xperience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry or Contract Research Organization environment. • Experience leading submission authoring and authoring submission level documents . • Understanding of the drug development process from development through life-cycle management . • Experience in working within , and contributing to , large, diverse , matrix teams. • Excellent verbal and written communication skills in English. • In depth knowledge of the technical and regulatory requirements related to the role. • Flexibility in adapting to changing circumstances and latest information . Desirable Qualifications: • Advanced degree in a scientific discipline ( Ph.D . ). Why AstraZeneca? At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare. So, what’s next? Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! The annual base pay (or hourly rate of compensation) for this position ranges from $ 136,784.80 - $205,177.20 USD . Hou rly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried r