Manager, Expert Scientific Writer at Bristol-Myers Squibb

Kariya-shi, Aichi, Japan

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, BiotechnologyIndustries

Requirements

B.S. in medical / pharmaceutical / veterinarian / life-science area or three years or more experience in either pharmaceutical R&D industry is mandatory
PharmD/PhD/MD in a relevant scientific discipline, or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in preparing regulatory submission documents or have equivalent credentials and experience
Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
Good understanding of the tendency of each review department

Responsibilities

Lead the authoring of clinical/regulatory documents in Japan, including clinical study reports (CSR) for local Ph 2 or 3 study, regulatory submission documents (CTD), briefing document for PMDA consultation, regulatory response documents, orphan drug designation
Lead the authoring of clinical/regulatory documents and support the performance goals (including quality and timeline) for the clinical development and regulatory submission in Japan as planned by the R&D Development Teams
Establish cross-divisional cooperative partnership with other functions according to the optimized and standardized processes and systems
Fulfill the role of Japan Documentation Lead
Build the storyboard to author regulatory dossier policies and align with global team based on the information provided by DT
As DOC lead, understand the global authoring regulatory dossier strategy and lead the finalizing of domestic regulatory dossiers of clinical part
Set an appropriate and the shortest timeline to complete authoring regulatory dossiers and comply with the timeline
Propose to the team the optimal strategy for preparing regulatory submission documents based on the tendencies of each review division concerning the contents of PMDA review reports and inquiries
Complete the clinical modules with J-CDL/J-CS based on the storyboard
Manage and provide global submission materials to stakeholders as needed
Authoring and conducting a coordinating activity as CSR author
Take charge of the CSR authoring part in the inspection
Manage the operational execution by strategically using outsource vendors and ensure quality of deliverables
Comply with internal and external processes and guidelines
Review and edit other clinical/regulatory documents as required
Drive continuous process improvements by identifying and simplifying processes. Lead implementation of business process improvements based on information from collected metrics
Give advice to other scientific writers to help them improve their capabilities in creation of clinical/regulatory documents for Japan
Provide additional value by creating better collaborative work environment internally and externally to ensure that Japan team has a good communication with HQ counterparts as well as key stakeholders, such as clinical research and regulatory

Skills

Scientific Writing

Clinical Study Reports

Regulatory Documents

CTD

PMDA Consultation

Orphan Drug Designation

Storyboard Development

Document Leadership

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters

1887Year Founded

$33,706.1MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Flexible Work Hours

Hybrid Work Options

Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.

BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.

Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.

The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.

BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.

The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.

BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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