Job title
:
Project Specialist- Electronic Documentation Specialist (eDS)
Opella is the self-care challenger with the purest and
third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally
.Our mission is to bring health in people’s hands by
making self-care as simple as it should be
. For half a billion consumers worldwide – and counting.At the core of this mission is our
100 loved brands
, our
11,000-strong global team, our 13 best-in-class manufacturing sites
and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
B Corp certified in multiple markets
, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.
About The Job
Our Team:
The Global Hub is an internal resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. The Global Hub strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations locally & globally.
Main Responsibilities
To ensure the format and submission-readiness validation of all documents that need to be prepared in the official electronic Document Management System (eDMS) such as clinical documents, CTD, PSMF, etc. Perform compilation/publishing of documents and implement navigation required to submit dossiers to Health Authorities. The eDS works in close collaboration with the teams responsible for the operational delivery of the documents.
Essential Job duties and responsibilities: 1) Propose technical solutions based on previous experience and expertise gained within the eDS role. 2) Strong and thorough knowledge of MS WORD functionality and advanced skills in using Adobe Acrobat. 3) Organization and Prioritization: Organize and prioritize workload/multiple requests to comply with agreed-upon timelines and ensure that business needs are met. 4) Negotiation: Understand valid criteria for challenging various demands of users/customers. Be able to understand and identify priorities for the purpose of negotiating timelines. 5) Actively leads and develops Global Hub operations activities. 6) Ensure new technologies are leveraged. 7) Follow-up with the Medical Writers and other contributors for performing submission readiness. 8) Provide 1-1 support to authors/contributors and eDMS Users. 9) Participate in the review of eDMS-related guides, as appropriate. 10) Coordinate work that is subcontracted to vendors/CROs, providing technical support to vendors, seeking/identifying solutions, facilitating interaction and exchange of information, and overseeing/managing vendor activities. 11) Collaborates effectively with internal members of Clinical Documentation, such as medical writers and record managers, as well as contributors from other functional areas, including (but not limited to) Regulatory, Pharmacology, Statistics, Clinical Leaders, and Project Leaders. 12) If require, eDS may act as an alliance with the project specialist to learn and develop the end-to-end process through Datavision, Matrix, approval/compliance tools (e.g., PromoMats, NAYA), or any contracting database.
- People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) with an end objective to develop education and communication content as per the requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist medical regulatory writers in submission readiness activities, as required.
- Performance: 1) Ensure electronic documentation/publication materials are delivered and stored as per agreed timelines and quality. 2) Perform format and submission-readiness validation of clinical documents. Publish/compile clinical documents that consist of multiple components. 3) Create clinical documents and “binders” (as applicable) in the frim's eDMS. Ensure conformity of clinical documents (e.g., naming conventions, and metadata within the eDMS). 4) Set links within documents (internal) and publish/compile clinical documents (including CSR, CO, and Clinical Summaries) as required, including review and confirmation of the feasibility of publishing/compilation of Micro plans (timelines), monitoring the availability of appendices, performing format and submission-readiness validation on appendices, compiling all documents in the required/correct order and performing format and submission-readiness validation on the publishing/compilation. 5) Electronically approve, within the eDMS, all clinical documents.
- Process: 1) Support the delivery of projects in terms of resourcing, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports in the document management system/ approval-compliance. 2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group. 3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with all applicable regulatory standards. 4) Support Regulatory team in the contribution of submission-ready clinical documents for applications in electronic Common Technical Document (eCTD) format. 5) Support Medical Writers in the completion of the electronic Table of Contents (eTOC) dossier-planning spreadsheet. 6) Perform transversal activities, including identifying the need for eDMS user training, communicating the user needs, performing specific types of training, and participating in the development of new tools.
- Stakeholders: Liaise with the Medical department to prepare relevant & customized deliverables.
About You
- Experience: 1-3 years of experience in the pharmaceuticals industry is preferred (electronic Documentation Specialist/ Project Management experience); Industry experience should be within comparable sectors or roles (computer systems, electronic document management systems/ project specialist role).
- Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment
- Technical skills: As applicable (Including but not limited to Knowledge of Clinical development, submission dossiers and procedures preferred, Awareness of Specific software tools such as eDMS, Veeva Vault RIM, publishing tools, Acrobat (ISI Toolbox) and MS Office 365 environment are an added advantage)
- Education: Graduate / Post Graduate degree in life science preferred
- Languages: Communicate effectively both spoken and written
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We Are Dedicated To Making Self-care As Simple As It Should Be. That Starts With Our Culture. We Are Challengers By Nature, And This Is How We Do Things
All In Together:
We keep each other honest and have each other's backs.
Courageous:
We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed:
We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple:
We strive to make things simple for us and simple for consumers, as it should be.Join us on our mission. Health. In your hands.www.opella.com/en/careers
