Clinical & Medical Affairs Manager, APAC
Consultant Archita Tekriwal (R1659919)
Date posted 23 January 20186 Battery Road Singapore 049909 Robert Walters Singapore
An exciting new hybrid Medical Affairs and Clinical Affairs job covering the entire APAC region has just opened up for a globally renowned Pharmaceutical Company. This business critical role is a newly created headcount for the year and reporting directly to the APAC Medical & Clinical Affairs Director.
About the Clinical & Medical Affairs Manager, APAC Role:
This newly created role will be part of the Clinical Trials Operations Coordinating Unit and work closely with the Regional Medical & Clinical Affairs Director to provide scientific support to Regulatory Affairs and Business Development for company's entire product portfolio (across various Therapeutic Areas).
- Provide scientific and medical advice for registration studies, investigator initiated studies, RMPs, clinical studies arising as a post-approval commitment/requirement and marketing studies
- Support the development of clinical data through Medical Affairs Sub-Team to include sponsored, investigator-sponsored and collaborative studies
- Provide scientific expertise into study concepts; participate in building study synopsis, protocols, and other study documents; and liaise with affiliates and investigators
- Responsible for data entry into clinicaltrials.gov and corporate website of ongoing and completed clinical trials
- Responsible for approval of all product promotional material, in compliance with corporate standards government/industry regulations and to ensure the highest degree of medical and ethical standards.
- Provides medical information to the medical representatives, marketing team, business development team, doctors, patients, and regulatory agencies in order to address their questions, issues and concerns about company products;
- Monitor competitive and regulatory landscape (e.g. guidance from FDA, competitive clinical studies, etc.)
To be successful in this role, you will need to work effectively in a cross-functional team.
- At least three years' experience in a Pharma company, preferably in both Clinical Research and Medical Affairs
- Proficient knowledge of medical terminology and clinical research study design
- High attention to details and accuracy, database experience preferred
- Strong organisational skills and ability to work with minimal supervision
- Excellent communication skills
- Bachelor’s degree in Biostatistics, Life Science or equivalent, MD or PhD preferred
- Ability to Travel up to 25% across the region
This company is a recognised leader in areas of its speciality, with double digit year-on-year growth in the region. If you are driven and want to take the next step in your career, great progression opportunities await the right person in this exciting new role.
If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting job.
Apply today or email me for further information.
Robert Walters (Singapore) Pte Ltd
ROC No.: 199706961E | EA Licence No.: 03C5451
EA Registration No.: R1659919 Archita Tekriwal