Top 89 Pacific Rim Partners Jobs

Associate Director, Medical Writing
CALICO —South San Francisco, CA
- $230,000 - $240,000 a year
- Master's degree
- 8 years
- Doctor of Philosophy
RETAIL MERCHANDISER- Military
GENERAL PRODUCE DISTRIBUTION COMPANY, LLC —Fallon, NV
- $20 an hour
- Full-time
- 18 years or older
- Customer service
- Ability to walk for extended periods
- Paid holidays
- Health insurance
2d
Critical Care Nurse - Clinical Solution Specialist (Travel: Southwest US and Pacific Rim)
Philips —Albuquerque, NM
- $90,000 - $143,000 a year
- Full-time
- Nursing
- RN License
- Hospital
- Health savings account
- Employee stock purchase plan
Systems Solutions & Adoption Lead
Moffatt & Nichol —Chipley, FL
- Full-time
- Background check
- Computer science
- 7 years
- Wellness program
- Health savings account
Quick Apply
Chef de Cuisine - Tidepools Restaurant
Grand Hyatt Kauai —Koloa, HI
- $76,700 - $115,300 a year
- Full-time
- Cooking
- Mid-level
- 3 years
Overnight Cleaner - Waikoloa (Full &Part-Time)
Ganir & Co —Waimea, HI
- $18 - $20 an hour
- Overtime
- Basic math
- English
- Hotel
- Health insurance
- 401(k)
Quick Apply
Senior Environmental Planner
SSFM —Honolulu, HI
- $110,000 - $120,000 a year
- Full-time
- Mentoring
- Budgeting
- Senior level
- Paid holidays
- Health insurance
Quick Apply
Clinical Assistant Professor of Pediatrics (Practitioner) Division of Cardiology-CHLA
USC —Los Angeles, CA
- $95,904 - $325,712 a year
- On call
- Medicine
- Outpatient experience
- Perioperative Care
Relationship Manager, Pac Rim Division
BMO Financial Group —San Francisco, CA
- $88,800 - $165,600 a year
- Full-time
- 7 years
- Office
- Finance
- Health insurance
- Tuition reimbursement
Property Manager - Business Development
Pacific Rim Property Management & Maintenance Solutions —Poway, CA
- Full-time
- Computer literacy
- Research
- Mid-level
Superintendent
Pacific Rim —Tamuning, GU
- Full-time
- Construction site
- Engineering
- Math
Quick Apply
Director of Operations
TelemetryX —Irvine, CA
- $158,000 - $223,000 a year
- Full-time
- System design
- Master's degree
- Organizational skills
- Paid holidays
- Health insurance
Quick Apply
11d
Footwear Innovation Lab Instructor
University of Oregon —Portland, OR
- Email
- Background check
- Laboratory
- Anatomy knowledge
- Paid time off
- Retirement plan
12d
Development Manager / Technical Lead for Engineering Consultant
Moffatt & Nichol —Southlake, TX
- Full-time
- Background check
- Computer Science
- 5 years
- Wellness program
- Health savings account
Quick Apply
Transportation Engineer - Senior Level
Moffatt & Nichol —Costa Mesa, CA
- $274,000 - $360,000 a year
- Full-time
- Background check
- 11+ years
- Office
- Wellness program
- Health savings account
Quick Apply
9d
Senior Strategic Account Manager - North America (Refining & Petrochemical) Process Analyzers
PAC —Houston, TX
- Remote
- Up to 50% travel
- Engineering
- 11+ years
- Health savings account
- Health insurance
Quick Apply
Transportation Planner - Senior Level
Moffatt & Nichol —Lake Mary, FL
- Full-time
- Background check
- 11+ years
- Research
- Wellness program
- Health savings account
Quick Apply
Prep Cook
Roy's —San Diego, CA
- $17.25 - $21.00 an hour
- Multiple hires
- Basic math
- English
- Ability to lift 50 pounds
Quick Apply
Operations Manager
Pacific Rim —Tamuning, GU
- Full-time
- Construction site
- Bachelor of Science
- 11+ years
- AD&D insurance
- Disability insurance
Quick Apply
Warehouse associate / Backup delivery driver
Pacific Rim Packaging —‘Aiea, HI
- $20 - $22 an hour
- Overtime
- Microsoft Outlook
- Customer service
- Computer literacy
- Profit sharing
- Paid holidays
Quick Apply
12d

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Associate Director, Medical Writing

CALICO -
South San Francisco, CA

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Job Details

$230,000 - $240,000 a year

Qualifications

FDA submissions
Technical writing for researchers
Medical writing
Clinical study protocols and reports
Contractor management
Resource allocation (project management tasks)
Drug regulation
Master's degree
ICH guidelines
Scientific protocols
Compliance documentation
Clinical data report preparation
Vendor relationship management
Collaborative technology platforms
Regulatory submission editing and review
Clinical quality assurance standards
Clinical research reports
Document management systems
Adobe Acrobat
Stakeholder management
Scientific reports

Full Job Description

Who We Are:

Calico (Calico Life Sciences LLC) is an Alphabet-founded research and development company whose mission is to harness advanced technologies and model systems to increase our understanding of the biology that controls human aging. Calico will use that knowledge to devise interventions that enable people to lead longer and healthier lives. Calico’s highly innovative technology labs, its commitment to curiosity-driven discovery science and, with academic and industry partners, its vibrant drug-development pipeline, together create an inspiring and exciting place to catalyze and enable medical breakthroughs.

Position Description:

Calico is seeking an Associate Director, Medical Writing to provide leadership and functional oversight for writing and leading the review/approval process of high quality clinical and regulatory documents, in compliance with applicable guidelines and regulations. The successful candidate should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment. This role will function as a strong project manager and technical leader with demonstrated scientific and stakeholder-focused leadership skills.

Key Responsibilities:

Document Leadership and Authoring:
- Provides medical writing leadership for clinical programs
- Acts as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator’s Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)
- Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissions
Vendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activities
Process Improvement:
- Develops medical writing best practices (e.g. standard timelines, clinical document templates, Calico Style Guide)
- Partners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirements

Position Requirements:

Master’s degree in a life science discipline from an accredited college or university; PharmD or PhD preferred
Minimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization setting
Expert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)
Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator’s Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study Trials
Expert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)
Experience in resource planning and management experience of contractors
Excellent organization skills with a passion for delivering quality results
Detail-oriented mindset with excellent verbal and written communication skills
Self-motivated and able to work collaboratively
Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
Must be willing to work onsite at least 4 days a week

The estimated base salary range for this role is $230,000 - $240,000. Actual pay will be based on a number of factors including experience and qualifications. This position is also eligible for two annual cash bonuses.

Apply Now

Refine Your Search

Pacific Rim Partners jobs

Associate Director, Medical Writing

RETAIL MERCHANDISER- Military

Critical Care Nurse - Clinical Solution Specialist (Travel: Southwest US and Pacific Rim)

Systems Solutions & Adoption Lead

Chef de Cuisine - Tidepools Restaurant

Overnight Cleaner - Waikoloa (Full &Part-Time)

Senior Environmental Planner

Clinical Assistant Professor of Pediatrics (Practitioner) Division of Cardiology-CHLA

Relationship Manager, Pac Rim Division

Property Manager - Business Development

Superintendent

Director of Operations

Footwear Innovation Lab Instructor

Development Manager / Technical Lead for Engineering Consultant

Transportation Engineer - Senior Level

Senior Strategic Account Manager - North America (Refining & Petrochemical) Process Analyzers

Transportation Planner - Senior Level

Prep Cook

Operations Manager

Warehouse associate / Backup delivery driver

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