by OMC Medical | Apr 20, 2023 | Uncategorized
Business Development Executive – Job Description
Job Summary
OMC Medical is seeking a Business Development Executive to join our growing team, to be office-based and be responsible for driving new sales in regulatory (Medical devices, cosmetics, Drugs). This position is closely aligned with internal teams and is responsible for communicating both the quality and operational benefits of services to prospective clients. Also, as part of the Business Development team, the individual in this role will contribute to the continued growth and success of OMC Medical by offering high levels of customer support to existing clients.
Responsibilities
- Actively prospect and generate new sales and business opportunities within assigned customer territory;
- Cultivate strong, long-term relationships with customers and develop in depth knowledge of their organization and needs;
- Collaborate with internal staff regarding the development and procurement of proposals;
- Establish and maintain frequent contact with customers through focused client visits and presentations;
- Support marketing initiatives when necessary (e.g., tradeshow, symposia attendance);
- Maintain contacts with appropriate sales activity data within OMC Medical-sponsored Customer Relationship Management database; and
- Perform general strategic and tactical account planning, management, and execution.
Qualifications
- Bachelor’s degree, Master’s Degree and/or PhD in the medical or pharmaceutical field.
- Fluent English language and any EU language preferred.
- Previous experience selling within a medical device/drugs/cosmetics sector
- Ability to recognize the needs of the customer and collaborate with the clinical areas to develop proposals that exceed customer expectations.
- Must be reliable, highly motivated, well-organized, results-oriented, customer-focused, and possess excellent interpersonal and presentation skills.
- Familiar with using Share point.
- Proficient in Microsoft Office.
- An established network of contacts within the industry (preferred).
Travel: 30-60%
OMC Medical Overview
OMC Medical is service oriented company within the medical devices, drugs, and pharmaceutical sector focussing on Regulatory and Quality aspects of a product right from design until the End of Service. Our services range from initial design consultation, writing technical files, submitting for notified body approval, distributor set up, local country registration, and post-market product support etc., Our Headquarters is based in the UK and we have offices across the globe. We are a rapidly growing company, and our clients range from starts ups with breakthrough medical technology up until the top 10 medical product manufacturers. Our mission is to accelerate the global development of safe and effective medical products through its regulated and quality approach.
by OMC Medical | Sep 22, 2022 | Uncategorized
eCTD-an overview
In today’s economy, life science companies are seeking for strategies to continue growing despite impending patent expirations, increasing generic competition, and rising drug development costs.
The International Conference on Harmonization (ICH) created the Common Technical Document (CTD), which is quickly replacing other submission formats as the preferred or compulsory one by regulators in the major global markets and beyond. In Europe, Japan, and Canada, the CTD has been required for marketing and post-marketing applications since July 2003. Since 2008, the Food and Drug Administration (FDA) has required submissions in the eCTD format which adds additional parameters, such as PDF, transmission, file format, and supporting file specifications, to its requirements for eCTD submissions. By the beginning of 2010, the European Medicines Agency (EMEA) expects all centralized Procedure applications to be submitted in the eCTD format.
A worldwide interface and specification for the delivery of regulatory information from the pharmaceutical industry to agencies is the electronic common technical document (eCTD). The Electronic Common Technical Document Specification, the main standard developed by the ICH, substantially determines the structure of an eCTD submission. However, in national and continental situations, further parameters might be used.
The eCTD has five modules:
- Administrative information and prescribing information.
- Common technical document summaries.
- Quality(CMC)
- Nonclinical study reports.
- Clinical study reports
There are two categories of modules:
- Regional module: 1 (different for each region; i.e., country)
- Common modules: 2–5 (common to all the regions)
The following are the main technological elements:
- A high-level folder structure
- An XML “backbone” file
- An optional lower-level folder structure (recommended folder names are provided in Appendix 4 of the eCTD specification)
- Associated document type definitions (DTDs) and stylesheets
Checklist for eCTD Submission
- eCTD Software
- Software training and support from the supplier
- Compiling and eCTD
- eCTD hyperlinking
- QC of eCTD
- Use the electronic gateway to submit your eCTD or a CD/DVD
eCTD Characteristics include:
- Granularity settings are available for all modules 1 through 5 to enable higher document granularity.
- PDF documents linked via XML backbone
- Transparency to the entire submission
- Ease of navigation and review
With the help of the eCTD’s features, submission and review periods can be sped up. One such feature is cross-application linking, which enables sponsors to submit a document just once and use it as many times as necessary in subsequent submissions and applications. Cross-application linking is a crucial time-saving feature of an eCTD because it enables the ability to reuse submission documents and to apply granular document updates to all linked occurrences elsewhere across related product applications (either while building the current submission or while applying a lifecycle attribute in a future sequence). This lifecycle management capability boosts publisher productivity and helps maintain uniformity of information throughout the product application portfolio.
The ability of the eCTD to map to documents within and across all submissions and applications is one of the benefits of electronic transmission, administration, and storage. If correctly configured and controlled from the beginning of the product IND application, this functionality can reduce time and costs.
Challenges
Despite all the advantages provided by the eCTD framework’s standardisation, there are still several drawbacks to this submission format that make it difficult for life sciences businesses to use. Finding the regulatory tools that support the software abiding to the requirements for eCTD filing is the main challenge.
Other Challenges Include;
- Regional variations in the PDF version, bookmarking, and hyperlinking
- If the concerned employee quits, the product knowledge is lost.
- Lifecycle management is difficult.
- A consolidated approach to dossier drafting
- Baseline submissions are expensive and maybe of little benefit.
- Implementing last-minute modifications is challenging
Many pharmaceutical companies are making the switch to eCTD barely in time for regulatory deadlines, despite the fact that the industry has been preparing for change for some time. Due to poor planning and understanding, many of the technical benefits of eCTD are sometimes lost as businesses struggle with new formats and procedures and fail to adequately plan for the product lifespan.
FAQS
Why eCTD is important?
By enabling sponsors to reuse and recycle previously published and submitted materials both inside a single submission and across all product applications, the eCTD format offers a platform for time savings and future product growth.