Job Title: Lead Medical Writer

Company Overview: ( https://www.tatvacare.in/)

Tatvacare is a cutting-edge digital health company based out of Ahmedabad, Bangalore and New Delhi. We provide comprehensive technology solutions that enhance the interactions between patients and doctors, leading to significantly improved health outcomes. With a focus on innovation and service, Tatvacare is poised for rapid growth due to its focused new age digital health tech products.

Purpose of position:

The Lead Medical and Scientific Writer is responsible for developing and reviewing high-quality medical content, including scientific publications- Original research articles, Consensus, Expert Opinions, Review Articles, Meta-analysis, Case reports and series, Narratives, clinical trial documentation, regulatory submissions, and real-world evidence (RWE) reports. This role involves collaborating with cross-functional teams, providing scientific expertise, and ensuring compliance with regulatory and industry standards. The ideal candidate will have extensive medical writing experience, particularly in clinical development, regulatory affairs, and digital health research.

Responsibilities:

1. Medical Writing Strategy:

- Document Preparation, Development and Finalization/Document Management/Review

- Help evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.

- Plan, review, coordinate and complete the publication of scientific data in peer-reviewed journals and forums.

- Conduct effective document initiation via a kick-off meeting to ensure authoring team alignment and understanding.

- Coordinate expert/scientific reviews, collate reviewer's comments, adjust content of document as required based on internal/external input, and prepare final version.

- Ensure and coordinate quality checks for accuracy.

2. Project and Stakeholder management:

- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality scientific publication deliverables.

- Build/Communicate credible writing project timelines.

- Anticipate and mitigate risks to delivery.

- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.

- Effectively communicate project status to stakeholders.

3. Knowledge Sharing

- Provide guidance to the team in review and writing of various scientific documents.

- Continuous Improvement & Feedback Mechanism

- Training & Mentoring the Medical Writing Team

- Compliance with Journal or Regulatory Guidelines

- Recognized for technical expertise in specific document development.

- Contribute to process improvements, suggesting opportunities where appropriate.

- Provide database and other tool (e.g., document management systems) expertise

Minimum Qualification Requirements:

- Advanced degree in a life sciences discipline (Medicine, Pharmacology, Biochemistry, Biotechnology, Public Health, or related fields).

- Experience in writing scientific publications.

- Strong communication and interpersonal skills.

Other Information/Additional Preferences:

Experience & Skills:

- 5+ years of experience in medical and scientific writing within pharmaceutical, healthcare, CRO, or digital health domains.

- Strong experience in writing scientific publications, regulatory documents, and clinical trial reports.

- Expertise in real-world evidence (RWE) research, systematic reviews, and meta analyses and other scientific publications.

- Proficiency in statistical interpretation and collaboration with biostatisticians.

- Demonstrated ability to publish in peer-reviewed journals and present at conferences.

- High proficiency in English (verbal & written), with strong attention to detail and scientific accuracy.

- Ability to work under strict timelines and manage multiple projects efficiently.

Technical Proficiency:

- Expertise in Microsoft Office Suite (Word, Excel, PowerPoint).

- Experience with reference management tools (EndNote, Zotero, Mendeley).

- Familiarity with statistical analysis software (SPSS, SAS, R) for data interpretation.

Other Preferred Skills & Attributes

Previous experience in:

- Health Economics & Outcomes Research (HEOR)

- Adherence to ICMJE, CONSORT, PRISMA, and GPP guidelines.

- Compliance with the target journal's author instructions (word limit, reference style, formatting).

- Ethical considerations such as disclosures, conflicts of interest, and authorship criteria.

- Developing patient-centric materials and healthcare communication strategies.

Soft Skills:

- Strong leadership, strategic thinking, and mentorship abilities.

- Ability to synthesize complex clinical data into clear and concise scientific writing.

- Excellent communication & stakeholder management skills.