As a Medical Writer, you will prepare regulatory submission documents (eg, clinical overviews, clinical summaries, Risk Management Plans, Periodical Safety Reports). You will need to convey scientific information clearly, accurately and concisely and work closely with colleagues from different countries and departments.
You will be able to work from home as a contractor, with a regular 8 hours a day schedule.
- Conduct global/systematic search and review of abstracts and full text publications to use as bibliographic support for CTD Modules, Risk Management Plans (RMP) and Periodic Safety Update Reports (PSURs).
- Compile and update RMPs and respond to request for further information from regulatory authorities or client related to RMPs.
- Prepare clinical and non-clinical overview as per the ICH templates and guidelines.
- Provide support in the revision and analysis of the client SPC, PIL and relevant documents.
- Update the clinical and non-clinical overview as required by the client (MAH) or regulatory authorities.
- Provide support in compilation of the PSUR for regulatory submission.
- Review and analyse relevant safety articles for PSUR compilation.
- Submit data on medicines in accordance with Article 57(2) of Regulation (EC) 726/2004, as per SOPs, WIs and guidelines.
- Perform monthly local literature search for specific APIs and for specific countries in accordance with internal SOPs and guidelines.
QUALIFICATIONS AND KEY ATTRIBUTES:
- Medical or Life Science degree is mandatory, preferably MA/PhD
- Must have experience in medical writing – a focus on writing regulatory submission documents is a plus
- Excellent verbal and written communication skills
- Able to handle multiple projects at the same time
- Able to liaise effectively with the internal project team and management
- Proficient in MS Office (Word, Excel, PowerPoint)
- Organized, motivated, influential and client orientated team player who works just as well independently
ELC GROUP is a leading global services organization that helps clients expedite time-to-market through our services. These include a broad range of development capabilities, integrated advanced technologies, regulatory affairs consulting, and commercialization services.