Novartis · 1 day ago
Senior Scientific/Regulatory Writer
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BiotechnologyHealth Care
No H1B
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Responsibilities
To author and review high quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
Lead for outsourced Narrative projects. Coordinate other outsourced activities in RWS.
Core member of Clinical Trial Team (CTT) / participate in Safety Management Team(SMT).
Actively participate in planning of data analyses and presentation used in CSRs.
Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
Support the development of RWS through participating in RWS workstreams and other related activities.
Qualification
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Required
Minimum university life science degree or equivalent is required.
≥ 2 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the medical writing processes.
Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
Knowledge of process for and some experience in global registering of drugs (simple submissions).
Excellent communication skills (written, verbal, presentations).
Preferred
Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
Benefits
Sign-on bonus
Restricted stock units
Discretionary awards
Full range of medical
Financial
401(k) eligibility
Various paid time off benefits, such as vacation, sick time, and parental leave
Company
Novartis
Novartis is a healthcare company that provides solutions to address the evolving needs of patients worldwide.
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Recent News
2024-12-24
2024-12-23
San Francisco Business Times
2024-12-19
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