Great Opportunity as Officer at Sun Pharmaceutical- Apply 25th July 2024

Job Posting: Officer

Job Description

Role and Responsibilities The Officer will be responsible for preparing high-quality clinical protocols, investigator brochures, regulatory documents, data reviews, clinical study reports, publications, and other related clinical documents. The role includes manuscript writing, preparing posters/abstracts for conferences, coordinating with vendors for outsourced activities, and assisting in the procurement of scales.

Systems and Processes

• Adhere to all clinical and regulatory guidelines, processes, and systems for medical science activities, ensuring compliance with internal medical writing SOPs for clinical trials.
• Follow established procedures to write and review protocols for new trials, working closely with the operations team to ensure high-quality, operationally feasible protocols.
• Coordinate the review process for all study synopses from clinical, regulatory, and operational perspectives.
• Prepare and review SOPs specific to medical writing for clinical trials.
• Collaborate with medical monitors for the review of study documents (e.g., statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities.
• Lead process improvement initiatives and create metrics to assess performance, implementing plans for course correction as needed.
• Proficient with systems (MedDRA and WHO-DD) for data coding, including the coding of adverse events and drugs.
• Possess a good understanding of different randomization procedures and blinding techniques used in clinical trials.

Activities

• Responsible for clinical trial medical science-related activities, including the preparation of protocols, Clinical Study Reports (CSR) and appendices, and SOPs in line with ICH GCP requirements, as well as Indian and global regulatory requirements.
• Conduct relevant literature searches required for protocol, CSR, and manuscript writing.
• Write clinical journal manuscripts, abstracts, and study articles for publication.
• Prepare protocols and clinical study reports for presentation in subject expert committee (SEC) regulatory meetings.
• Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs (Patient-Reported Outcomes).
• Coordinate with the data management team to ensure timely data review, data cleaning activities, database lock, and release of tables, figures, and listings (TLFs).
• Work with biostatisticians early in the study process to engage with the study team for sample size certification, review of the statistical analysis plan (SAP), and review of mock/blinded tables, figures, listings (TFLs), and narrative and discussion planning for relevant documents in coordination with the medical monitor.
• Register clinical trials on relevant registries (e.g., CTRI).
• Ensure that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines.
• Create and maintain standard operating procedures and work instructions for the preparation and maintenance of compliant medical writing deliverables.
• Mentor and lead less experienced medical writers on complex projects as necessary.

Candidate Profile

• Educational background: B. Pharma/M.Sc/M.Pharma/PhD/BAMS/BHMS/life sciences.
• Relevant medical writing experience is desirable.
• Excellent medical writing skills.
• Familiarity with guidelines such as IMRAD, CONSORT, and other publication guidelines.
• Knowledge of current GCP/GDP regulations and thorough understanding of GCP guidelines, ICMR guidelines 2017, and Drugs and Cosmetic Act regulations pertaining to clinical trials, along with other regulatory guidelines like FDA.
• Experience working in matrix business environments is preferred.
• Strong track record of success demonstrated through annual performance ratings and/or professional accomplishments and awards.
• Comprehensive medical knowledge across different therapeutic areas.
• Strong functional knowledge of clinical research and medical writing activities.
• Ability to collaborate and work effectively in a matrix environment.
• Strategic thinking and sound analytical skills.
• Excellent writing and communication skills.
• Sense of urgency and desire to excel.
• Proficiency in Excel or software statistical tools.
• Self-awareness and adaptability to work in a matrix environment.
• Result-oriented and performance-driven.
• Excellent interpersonal and communication skills to interact with a broad range of audiences effectively.

Additional Information

• Qualification: B. Pharma / M.Sc / M.Pharma / PhD / BAMS / BHMS / life sciences
• Location: Mumbai
• Industry Type: Pharma/Healthcare/Clinical Research
• End Date: 25th July 2024

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