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Hoffmann La Roche
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Medical Writer

Medical Writer

Name: Jobpe
Address: T-Hub, Plot No 1/C, Sy No 83/1, Raidurgam panmaktha, Knowledge City Rd, Hyderabad, Telangana, 500081, IN
Telephone: +91-83339-09630
Price range: Free

Hoffmann La Roche

5 - 10 years

7 - 12 Lacs

hyderabad

Posted:1 day ago| Platform:

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Skills Required

rss time management pharma standard operating procedures healthcare ms office regulatory affairs medical writing monitoring clinical data

Work Mode

Work from Office

Job Type

Full Time

Job Description

In your capacity as a Regulatory Medical Writer, you will focus on crafting compliant medical documents that meet the rigorous standards of health authorities and regulatory bodies. You will also be responsible for maintaining a strong knowledge of medical terminology, guidelines, and regulations to ensure the accuracy and quality of all content produced.
In addition, you must stay up to date on industry trends and best practices in medical writing and content creation, continuously improving and evolving our strategies to meet the changing needs of our partners. Your expertise and dedication to producing high-quality content will help us deliver impactful and relevant materials that resonate with our target audiences and drive success for the organization.

The Opportunity

As a Regulatory Medical Writer, you must uphold the highest standards of scientific accuracy, quality, and compliance with all applicable industry guidelines, local and international.

As a qualified expert, your responsibilities will include, but are not limited to:

Writing and editing layperson clinical trial descriptions (lay CTD) and layperson summaries of clinical trial results (LPS), with the possibility of involvement in writing and editing CSRs, IBs, and QA documents.
Ensuring that the content, format, and structure comply with regulatory and other guidelines, as we'll as with Roches best practices
Attending meetings and collating the key points from the conversations
Exercising excellent interpersonal communication skills to effectively and professionally liaise with the internal teams, healthcare professionals, and other key stakeholders
Proactively contributing with creative ideas, concepts, or suggestions to provide added value
Working cross-functionally with global teams and pharma affiliates to develop various project deliverables
Take ownership of project kickoffs and manage stakeholder expectations
Diligently keeping up to date with and following all applicable company standard operating procedures (SOPs) to meet quality standards
Performing quality checks and proofreading for accuracy
Managing multiple concurrent projects across a range of therapeutic areas, ensuring projects are delivered on agreed timelines
Monitoring assigned tasks and managing own workload, taking ownership, and anticipating capacity issues and potential solutions

Who you are

We are looking for upbeat, dynamic individuals who are highly involved and passionate about medical writing. Ideally, you should have:

A degree in medical sciences or equivalent, eg, MBBS, Dentistry, PhD in Healthcare, Pharmacology
Preferably, a relevant certificate in medical writing, regulatory affairs, etc
5+ years of full-time work experience in a similar role
Ability to translate complex scientific or medical information into clear, simple language
Experience with standard IT applications, Google Suite, MS Office, etc
The ability to interpret medical and clinical data
Effective time management and excellent communication skills, both written and verbal
Ability to work in a fast-paced and changing environment, prioritizing tasks along the way

The Benefits

Development opportunities : Roche is rich in learning resources. We provide constant development opportunities, free language courses and training, the possibility of international assignments, internal position changes, and the chance to shape your career.

A global and diverse community : At Roche, we cooperate, debate, make decisions, celebrate successes, and have fun as a team. Our leadership is extremely focused on people, creating a strong and inclusive culture so you always have the chance to share your opinion.

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Medical Writer