Job Description

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com

Looking to jump-start your career?

We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast track career where you can grow along with Indegene’s high-speed growth.

We are purpose-driven. We enable healthcare organizations be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work.

If this excites you, then apply below.

Must Have

You will be responsible for:

· Responsible for authoring clinical evaluation reports, clinical evaluation plans, post-market surveillance reports, and periodic safety update reports

· Act as primary writer for the assigned deliverable

· Draft queries for Project Kick-off meeting/call

· Develop & maintain the assets tracker related to the deliverable

· Review received assets from client, update tracker and request for additional source documents as required

· Align with Peer-reviewer and Technical project lead on planned timelines for release of the deliverable

· Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes

· Participate in and/or perform comprehensive literature searches to support identified product lines and related clinical studies

· Stay informed about applicable clinical landscapes and trends

· Review literature search results and interpret and summarize risks, alternate therapies and device specific benefits; collect and summarize primary data to support risk assessment

· Critically appraise scientific literature and write clinical summaries for products literature to elucidate the clinical problem and current treatment techniques

· Evaluate data for similar competitor devices

· Perform data fact check of the documents authored

· Ensure documents comply with the client/regulatory requirements

· Participate in client calls per project requirements

· Compliance to quality, confidentiality, and security

· Adhere and follow quality systems, processes and policies

· Comply to training and specifications

· Ensure all the open action items in the drafts (if any) are notified to Client

· Perform a self Quality Check before sharing draft for review, update and sign the checklist

· Draft client calls MoMs and share with client for the assigned deliverable

About you:

· Understanding of medical devices or an overall understanding of the medical field.

· Understanding of EU MDR, MEDDEV 2.7.1 Rev 4, IMDRF and MDCG

· Strong flair and passion for technical writing.

· Strong written and verbal communication/presentation skills.

· Being up-to-date with the latest technical/scientific developments and relating them to various projects.

Must have:

· Graduate or Post Graduate in Life Sciences (Pharm.D/M.Pharm/BDS/MBBS) or Bio Medical Engineering with 3 to 4 years experience

· 2+ experience in med device clinical affairs domain

· Clear and effective communication, both verbal and written

· Excellent critical and analytical thinking skills.

· Able to work effectively with cross-functional teams.

· Strong communication, presentation and interpersonal skills with high attention to detail and organization.

· Consistent dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary

Nice to have: NA

Perks: NA

Good to have

EQUAL OPPORTUNITY

Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate’s merit and qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.