FSP Medical Writing Program Manager (Remote; India) at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Biotechnology, Clinical ResearchIndustries

Requirements

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years)
Experience in managing and directing large medical writing narratives projects required
Experience working in the pharmaceutical/CRO industry preferred
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
Solid project management skills to include resource management and timeline development for multi-writer projects
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Extensive knowledge of global, regional, national and other document development guidelines
Excellent oral and written communication skills with strong presentation skills
Effectively lead study teams
Excellent negotiation skills
Self-motivated and adaptable
Excellent judgment; high degree of independence in decision making and problem solving
Ability to mentor and lead entry-level staff

Responsibilities

Develops, monitors, and adapts project plans, timelines, and budgets/forecasts for large programs
Serves as the point of contact for risk escalation, evaluating and resolving or escalating risks related to project quality, budget, or timeline
Ensures compliance with quality processes and requirements for assigned programs, maintaining consistency within and between project documents
Develops, reviews, and manages performance metrics for assigned projects
Provides senior-level review of project materials
Trains medical writers on processes and technical aspects of program management
May serve as primary author who writes and provides input on study- and program-level regulatory documents

Skills

Program Management

Project Planning

Risk Management

Quality Compliance

Performance Metrics

Medical Writing

Regulatory Documents

Client Engagement

Mentoring

Training

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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