Thermo Fisher

Leading company in the technology industry

FSP Medical Writer

职能医疗/健康科技

级别中级

地点Bengaluru, India

方式现场办公

类型全职

发布2个月前

立即申请

Work Schedule Standard (Mon-Fri)Environmental Conditions Office Job Description Job Title: FSP Medical Writer At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: We are excited to be expanding our Medical Writing FSP Team in India. We are looking for a MW to be dedicated to a client in the FSP space; experience in Structured Content Authoring systems and automation to support delivery would be preferred. We are seeking a talented and experienced Medical Writer to join our team. The Medical Writer will be responsible for developing high-quality clinical and regulatory documents, ensuring they meet all regulatory requirements and company standards.Key Responsibilities:Write and edit clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions.Collaborate with cross-functional teams to gather necessary information and ensure the accuracy and completeness of documents.Ensure documents align with regulatory guidelines, company standards, and industry best practices.Provide input on document content, structure, and presentation.Review and provide feedback on documents prepared by other team members.Manage timelines and deliverables for assigned projects.Stay current with industry trends, guidelines, and regulatory requirements.Education and Experience: Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required; Advanced degree preferred. 2+ years regulatory writing experience. Experience working in the pharmaceutical/CRO industry required. Safety writing experience advantageous (e.g. DSUR)Experience working on structured content management system and AI-driven content creation, and familiarity with Natural Language Generation preferred. Knowledge, Skills, and Abilities: Excellent organizational and program management skills Proven leadership skills to manage and mentor a team of medical writers.Extensive knowledge of regulatory guidelines and drug development processes Strong interpersonal and communication skills to build and maintain effective working relationships with colleagues and stakeholders Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards Self-motivated and adaptable Excellent judgment; high degree of independence in decision making and problem solving What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.   As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.  Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values
Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #Start Your Story with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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关于Thermo Fisher

Thermo Fisher

Public

Thermo Fisher Scientific Inc. is an American life science and clinical research company. It is a global supplier of analytical instruments, clinical development solutions, specialty diagnostics, laboratory, pharmaceutical and biotechnology services.

10,001+

员工数

Waltham

总部位置

$200B

企业估值

评价

10条评价

3.5

10条评价

工作生活平衡

2.8

薪酬

3.2

企业文化

4.1

职业发展

2.9

管理层

2.7

65%

推荐率

优点

Great team culture and dynamics

Excellent benefits and health plans

Supportive management

缺点

Heavy workload and frequent overtime

Poor management and lack of direction

Limited advancement opportunities

薪资范围

2,095个数据点

Junior/L3

Mid/L4

Junior/L3 · DATA ANALYST

1份报告

$130,000

年薪总额

基本工资

$100,000

股票

奖金

$130,000

面试评价

3条评价

难度

3.3

/ 5

时长

14-28周

录用率

33%

体验

正面 0%

中性 67%

负面 33%

面试流程

Application Review

HR Screen

Hiring Manager Interview

Panel Interview

Offer

常见问题

Behavioral/STAR

Past Experience

Technical Knowledge

Culture Fit