Senior/ICF Medical Writing Project Manager

Serbia

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Biotechnology, Clinical ResearchIndustries

Requirements

Candidates should possess a Bachelor's degree in a scientific field with at least 5 years of experience, or an advanced degree with 3 years of experience. Proven project management, budgeting, and forecasting skills are essential, along with strong planning, organizational, and communication abilities. Experience managing medical writing or clinical projects, preferably within the pharmaceutical/CRO industry, is required. Experience in regulatory and/or plain language medical writing is advantageous. Proficiency in global and regional regulatory guidelines is also necessary.

Responsibilities

The Senior/ICF Medical Writing Project Manager will lead initiatives to produce high-quality and compliant Informed Consent Forms (ICFs) and other critical documents. Responsibilities include developing project timelines, standards, budgets, and forecasts, and collaborating with cross-functional teams to meet deliverables. The role involves monitoring timelines, providing status updates, identifying and resolving client management issues, and ensuring compliance with quality processes.

Skills

Project Management

Medical Writing

Informed Consent Forms (ICFs)

Clinical Research

Budgeting

Forecasting

Client Management

Quality Assurance

Planning

Organization

Communication

Interpersonal Skills

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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