1,303 Freelance Medical Writer jobs in India

Role:

4 to 8 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5).

Required Skills

• Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs).
• Demonstrated excellence in focused/lean writing and editing following defined processes and templates.
• Lead cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions.
• Understanding of clinical development process from program planning to submission, including clinical trial design.
• Communication skills commensurate with a professional working environment.
• Effective time management, organizational, and interpersonal skills.
• People management experience for more than 2 years.
• Customer focus.
• Comfortable following directions, templates, and structured processes for delivering documents for review and finalization.
• Able to work independently while maintaining communication with the Sponsor’s MW project manager.
• Ability to move across Therapeutic Areas to support business continuity and resource needs.
• Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines.
• Develop work plan and ensure adherence.
• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion.
• Adherence to processes and Sponsor-defined best practices.
• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements.

Preferred Skills

• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States.
• Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries).
• Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science.
• Understanding of medical practices regarding procedures, medications, and treatment for different disease states.
• Manage messaging for consistency with historical information and in alignment with agreed-upon strategy.
• Capable of providing insight, alternatives, and suggestions based on previous experiences.
• Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring.
• Experience writing protocols, amendments, CSR, and CTD summary documents.

Pay range and compensation package

Pay range or salary or compensation.

Equal Opportunity Statement

Include a statement on commitment to diversity and inclusivity.

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Role:

4 to 8 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5).

Required Skills

• Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs), protocols, amendments, ICFs & amendments, and Investigator Brochures (IBs).
• Demonstrated excellence in focused/lean writing and editing following defined processes and templates.
• Lead cross-functional teams to draft agreed-upon scientific/medical content that addresses data interpretation, product claims, and internal/external questions.
• Understanding of clinical development process from program planning to submission, including clinical trial design.
• Communication skills commensurate with a professional working environment.
• Effective time management, organizational, and interpersonal skills.
• People management experience for more than 2 years.
• Customer focus.
• Comfortable following directions, templates, and structured processes for delivering documents for review and finalization.
• Able to work independently while maintaining communication with the Sponsor’s MW project manager.
• Ability to move across Therapeutic Areas to support business continuity and resource needs.
• Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines.
• Develop work plan and ensure adherence.
• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion.
• Adherence to processes and Sponsor-defined best practices.
• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements.

Preferred Skills

• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States.
• Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries).
• Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science.
• Understanding of medical practices regarding procedures, medications, and treatment for different disease states.
• Manage messaging for consistency with historical information and in alignment with agreed-upon strategy.
• Capable of providing insight, alternatives, and suggestions based on previous experiences.
• Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring.
• Experience writing protocols, amendments, CSR, and CTD summary documents.

Pay range and compensation package

Pay range or salary or compensation.

Equal Opportunity Statement

Include a statement on commitment to diversity and inclusivity.

``

Job Description for a Medical Communications Writer

The ideal candidate must have a strong background in medical and scientific writing, especially the medico-marketing/marketing communications. He/she must have a deep understanding of the pharmaceutical, life-sciences, medical devices and healthcare industry, and the ability to understand complex information and create a clear and an engaging content.

As a Medical Communications Content Writer, he/she will play a critical role in our efforts to deliver high-quality communication materials that support our clients' goals.

Key Responsibilities:

• Content Development: Ability to read and understand the project brief, guide the content writers and cross-functional teams on scope of work. Research, write, and edit a wide range of medical communication materials, including scientific manuscripts, medical marketing collateral, and educational content. Candidate must have a complete knowledge on the different types of marketing collaterals and best practices in creating such engaging content. He/she must be able to create content outline, storyline, and create/adapt the content to align the business/marketing objective, campaign plan and communication objectives. Review and proof-read the content for quality & accuracy. Different types of collaterals he/she must be able to create include:
• Print materials – Brochures, POS material, posters, newsletters, patient cards etc.
• Digital materials – Emails, iDetails, E-learning modules, social media posts, slides, PPTs etc.
• Audio-visual material – Educational videos, MoA Videos, 2d/3d animations etc.

• Scientific Accuracy: Must have a deeper understanding of medical science (subject matter expert) and must ensure the accuracy, integrity, and scientific rigor of all content by staying up-to-date with the latest developments in healthcare, pharmaceuticals, and relevant therapeutic areas.
• Audience Adaptation: Write/adapt/customize the content to diverse target audiences, including healthcare professionals, patients, and regulatory authorities, while maintaining scientific integrity and regulatory compliance.
• Collaboration: Collaborate with cross-functional teams, including medical experts, graphic designers, digital coding experts, project managers, clients & client servicing teams, to produce cohesive and effective communication materials. Liaise directly with clients and external stakeholders as required for the project.
• Regulatory Compliance: Adhere to industry guidelines, regulatory requirements, and ethical standards to ensure all content meets the highest standards of quality and compliance.
• People & Project Management: Manage multiple projects simultaneously, ensuring that they are completed on time and within scope. Work closely with peers & colleagues from content writing team; review the content created by fellow team members.
• Feedback Integration: Incorporate feedback from clients and internal stakeholders to continually improve and refine content.
• Content Approval Support: Must be aware of different types of submissions involved in content approval by clients/regulatory bodies/healthcare authorities preferably the US, UK, EU, middle east & Asian markets.

Qualifications & requirements:

• Master’s degree in a relevant field (e.g., life sciences, pharmacy) is required. Advanced degrees (e.g, PhD) is a plus.
• ≥3 years of experience in medical communications (preferably medico-marketing/promotional content), medical writing, or a related field.
• Strong understanding of the pharmaceutical and healthcare industry, including knowledge of clinical trials, drug development, regulatory processes, and marketing activities.
• Exceptional writing and editing skills, with the ability to convey complex scientific concepts in a clear and engaging manner. Ability to edit the content for language, grammar, standard styles, referencing styles etc.
• Proficiency with industry-specific software and tools (e.g., Microsoft Office, EndNote, and reference management software, Veeva Vault, Aprimo etc).
• Strong attention to detail and ability to work independently or as part of a team.
• Knowledge of industry guidelines, including ICH-GCP, PhRMA, and CONSORT, is a plus, although not mandatory.

MUST

• Be ready to work in different time zones as per the business need. Immediate need is to support the business in US/UK time zone
• Knowledge & Dmoain Experience with Veeva is mandatory. Hands on experience using Veeva Vault PromoMats, the submission process, workflows, M-L-R review and approval process is a must