**Greetings from You & I Consulting!**

We are proud to have helped candidates secure placements with over 64+ MNCs across India. At You & I Consulting, we continue to bring exciting opportunities to professionals looking to advance their careers.

Current Hiring for MNCs:

We are excited to share a great opportunity with a leading global MNC! Here's your chance to grow, explore, and take your career to the next level.

Role: Medical Writer

Location : Mumbai / Bangalore / Pune / Noida

CTC upto : 9LPA

Education : Any Life Science Graduate

Preferred experience for the role:

Authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigational plan, informed consent document, clinical study report, investigators brochure, clinical summary of pharmacology, clinical overview (efficacy and safety), briefing package/pre-meeting package preferred • Experience in preparation of clinical documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies • Clear, concise and scientific style of writing, with attention to detail • Strong analytical skills and expertise in writing and review of scientific/clinical documents • Good knowledge of clinical research domain, ICH GCP principles, Common Technical Document (CTD) structure and regulatory requirements

Responsibilities:

• Setting, discussing and meeting expectations of the document during kick off and subsequent meetings • Lead the authoring/editing of clinical documents, as mentioned above. • Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles,



guidelines • Perform quality review of the clinical documents within established timelines with adherence to applicable guidelines, templates, and processes • Ability to effectively and proactively communicate with internal and external stakeholders, including authors and key opinion leaders as appropriate (including problem-solving and resolution of issues) • Keep abreast of project status, clinical operating plans and ongoing/new studies as well as scientific literature within assigned project • Training and mentoring of the new recruits/existing medical writers • Oversee live projects assigned to the current medical writers and guide them as required • As required, take on functional role and responsibilities of the role of Documentation Lead o Lead PDRD deliverables for project and act as first point of contact for any information that is required for content/document preparation o Ensure alignment and content re-use across documents for a product o Onboard lead document writers on document content alignment and timelines. o Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy o Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review.

Work from Office

To Schedule an Interview:

Share your Cv - [email protected]

To Schedule an Interview:

Share your Cv - following format:

Name

Mobile Number

Email Address

Highest Qualification

Total Work Experience

Current Organization

Preferred Location

Last CTC

Expected CTC

Please note: Due to high call volumes, if the line is busy, kindly WhatsApp your details to the same number.

Interested candidates are also welcome to refer friends or relatives who meet the criteria.

We look forward to helping you take the next step in your career.

📌 Medical Writer Global MNC in Mumbai, Bangalore CTC - 9 LPA (Pune)
🏢 YOU & I CONSULTING
📍 Pune