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Senior Medical Writer

CELEGENCE
Bengaluru, Karnataka

Apply Now

Job details

Full-time

Qualifications

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Visio
English
Microsoft Office
Diagnostic evaluation
Master's degree
Bachelor's degree
Mentoring
Medical terminology
Communication skills

Full job description

Global Opportunities to Join the Celegence Team At Celegence, you have the opportunity to shine and truly make a difference. We have a growing organization where your inputs will be valued. We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds. Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment. Celegence is an Equal Employment Opportunity Employer All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment. Why work at Celegence? Be a part of a remarkable journey! Collaborative Team Here at Celegence, you get a great team that always stands by you. Supportive Manager A supportive Manager who makes sure you are absolutely comfortable with the work you’re doing. HR team An amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then). Leadership Team Here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.

Senior Medical Writer

Bengaluru, India
Full Time, Hybrid
Reporting to Senior Manager

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Education

Bachelor’s Degree / Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred.

Experience

5+ years in medical writing with a focus on regulatory submissions
Strong skills in assessing clinical claims, benefits, and interpreting safety/performance data
Solid understanding of GSPRs and their applicability
Experience in CER strategy assessment, gap analysis, and providing justification for identified gaps
Proven ability to resolve Notified Body observations on technical files and clinical documents

Technical/Functional Skills

Knowledge of clinical evaluation and related documents and regulatory requirements
Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature
Proficiency with Microsoft Office (Word, Excel, and Outlook)
Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills

Strong verbal and written communications skills
Ability to work as part of a team
A constant zeal towards learning and skill development
Potential to multitask and work within timelines
Ability to understand and deliver on customer requirements
Mentoring skills to act as trainer/mentor for junior members of the team

Personal Traits

Positive Attitude
Initiative and Commitment
Detail Oriented
Team player
Focused and sincere
Perseverance

Competencies

Basic English grammar, punctuation, and sentence construction
Logical comprehension
Knowledge of medical terminology
Excellent Communication (Writing and Verbal)
Quality focused mindset
Good time management
Good stakeholder management

Apply Now

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