❖ Medical Writing

• Drafting and reviewing regulatory documents including protocols, ICD, CSRs, IB, DSUR, clinical overviews, nonclinical overviews, safety summaries, ISS, etc.

• Providing guidance to other medical writers and cross functional team members for applying industry and medical writing best practices in various document preparations.

• Creating procedures and workflows related to the CDP, review, assess, and revise document preparation procedures and SOPs as to their efficiency, workflow, and implementation.

• Working along with the QA team for SOPs of various departments including the MW and regulatory, for technical, writing, and regulatory aspects.

• Working with teams to develop project specific metrics and strategies in line with standards.

             ❖ Medical Communications

• Preparing and implement the publication plans, including conferences, symposia, HCP programs and other scientific activities for communicating critical information 

• Responsible for medical information process and matrix driven delivery to internal and external stakeholders, question consolidation, and drafting standard responses

• Working on the scientific publications (review research, case studies, meta-analysis etc.) abstracts, posters, slide decks, and oral presentations to support the prime molecule.

• Responsible for collaboration with key stakeholders internally and externally (KOLs, patient advocacy groups, and professional societies, etc.)

• Working closely with medical affairs, clinical development, scientists, and other stakeholders to plan and execute the publication plans.

             ❖ Regulatory Affairs

• Responsible for preparation, compilation, review, & submission of dossier in eCTD & other formats for EU, US, and ROW market and answering to the questions or queries arising. 

• Providing guidance, decision and updates on various quality and regulatory issues to all departments across the organization and CROs for compliance and auditing purpose.

• Responsible for managing the SUSAR, and other regulatory submission activities.

• Liaising with the drug regulatory bodies including EMA, FDA, and ROW regulators.

• Independently managing all projects for US, EU, and ROW for the primary molecule and for the pipelines.

            ❖ Strategic Project Management

• Developing strategic medical writing plans in accordance with project objectives and in accordancewith applicable guidelines (ICH, CFR, etc.).

• Promoting document strategies and messages to relevant subject matter experts to ensure appropriate, factual and concise presentation of assigned documents.

• Managing and providing mentorship and guidance to MW staff (internal/external) to ensure document development activities are performed in accordance with medical writing plans.

• Leading regulatory problem solving and resolution efforts with strategic inputs for risk management, contingencies and the consistent compliance with SOPs and guidelines.

• Working across functional areas to obtain all applicable source material including routine engagements with clinical project managers and biostatistics.