This role will responsible for preparation of clinical high-quality protocol, investigator brochures, regulatory documents, data review, clinical study report, publications, and related clinical documents. Manuscript writing, poster/abstract preparation for conferences, co-ordinate with vendors for out-sourced activities and assist for procurement of scales.

YOUR TASKS AND RESPONSIBILITIES:

Systems and Processes:

Ensure to follow all clinical and regulatory guidelines, processes and systems for medical science activities and ensure compliance to internal medical writing SOPs for Clinical trial
To follow the designed process to write, review protocol for new trials and work closely with operation team to ensure high quality operationally feasible protocol for clinical trial
To co-ordinate with a process for review of all study synopsis from clinical, regulatory and operational perspective
Prepare and review SOPs specific for medical writing for clinical trial
Work closely with medical monitors for review of study documents (such as statistical analysis plan, data monitoring plan, coding plan, CRF) and data review activities
Identify, recommend and lead process improvement initiatives
Create and evaluate metrics to assess performance and implement plans for course correction
Well versed with systems (MedDRA and WHO-DD) for data coding including coding of adverse events and drugs
Good knowledge of different randomization procedures and different blinding techniques to be used in clinical trials
Identify, recommend and lead process improvement initiatives
Create and evaluate metrics to assess performance and implement plans for course correction.

Activities:

Responsible for clinical trial medical science related activities like preparation of protocol, Clinical Study Report (CSR) and appendices, and SOPs in line with ICH GCP requirement, Indian and global regulatory requirement
Conduct relevant literature search for required for protocol, CSR, and manuscript writing
Responsible for writing clinical journal manuscripts, clinical journal abstracts, and study article for publication
Responsible for preparation of protocol and clinical study reports presentation in subject s expert committee (SEC) regulatory meeting
Responsible for collaboration with vendors for manuscript writing, abstract/poster preparation, procurement of clinical scales/PROs (Patient reported Outcomes)
Responsible for coordination with data management team to ensure timely review of data extract and data cleaning activities to ensure timely database lock and release of tables, figures, and listings (TLFs)
Responsible for coordinating with biostatistician to engage early with the study team for sample size certificate, review of statistical analysis plan (SAP) apart from review of mock and/or blinded tables, figures, and listings (TFLs), and narrative and discussion planning for relevant documents in co-ordination with medical monitor
Responsible for registering on clinical trials registries (eg. CTRI)
Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
Responsible for mentoring and leads less experienced medical writers on complex projects, as necessary

WHO YOU ARE:

B. Pharma/M. Sc/M. Pharma/PhD/BAMS/BHMS/life sciences educational background
2- 8 years of relevant medical writing experience
Excellent medical writing skills
Well versed with different guidelines such as IMRAD, CONSORT and different publication guidelines
Well versed with different guidelines such as IMRaD, CONSORT and relevent publication guidelines
Well versed with current GCP/GDP regulations
Thorough knowledge of GCP guidelines, ICMR guidelines 2017 and Drugs and Cosmetic Act regulations pertaining to clinical trials and other regulatory guidelines like FDA
Experience of working in matrix business environments preferred
Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
Strong medical knowledge of different therapeutic area
Sound functional knowledge of clinical research and medical writing activities
Collaboration and teaming with ability to work in a matrix environment
Strategic thinking & sound analytical skills
Good writing and communication skills
Sense of urgency & desire to excel
Proficiency with Excel or software statistical tools.
Self-awareness and adaptability to work in a matrix environment
Result oriented and performance driven
Excellent interpersonal & communication skills to effectively interact with a broad range of audience