[Remote] FSP Senior Medical Writer (APAC) at Thermo Fisher Scientific

India

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical Research, BiotechnologyIndustries

Requirements

Bachelor's degree in a scientific discipline or equivalent relevant formal academic/vocational qualification; advanced degree preferred
Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 5+ years)
Experience working in the pharmaceutical/CRO industry preferred
Experience working within FSPs preferable
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
In some cases, equivalency consisting of a combination of appropriate education, training, and/or directly related experience considered sufficient
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Strong project management skills
Excellent interpersonal skills including problem solving
Strong negotiation skills
Excellent oral and written communication skills with strong presentation skills
Significant knowledge of global, regional, national, and other document development guidelines
In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc
Great judgment and decision-making skills
Excellent computer skills and skilled with client templates

Responsibilities

Serves as primary author for FSP clients who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies
May research, write or edit complex clinical and scientific and program level documents, including Protocol, CSRs, IBs, INDs, and MAAs
Reviews routine documents prepared by junior team members
May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge
Ensures compliance with quality processes and requirements for assigned documents
Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client specific processes
May assist in program management activities, including developing timelines, budgets, forecasts, and contract modifications
Identifies and resolves out of scope activities
Represents the department at project launch meetings, review meetings, and project team meetings

Skills

Medical Writing

Clinical Study Reports

Study Protocols

Investigator's Brochures

INDs

MAAs

Scientific Writing

Clinical Trials

Protocol Development

Data Summarization

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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