Regulatory Affairs, Translation, Medical Writing

ELC Group is recruiting for 3 different positions: Regulatory Affairs Project Manager, Translations Project Manager and Medical Writer. By joining our international team you will work closely with colleagues from different countries and departments and you will be a key contact person for our clients.

All three positions are remote, you will be able to work from home as a contractor, with a regular 8 hours/day schedule. If you are interested in any of our positions, please go to our website: https://elc-group.com/careers and apply from there.

KEY RESPONSIBILITIES:

Regulatory Affairs Project Manager

• Design and implement project plans by coordinating with other departments as well as with clients to ensure that projects are implemented, deadlines are met and deliverables are of high quality.
• Identify and report project and deliverable related risks to direct managers or relevant experts.
• Follow current Standard Operating Procedures (SOP) guidelines regarding procedural steps throughout the entire life cycle of the project.
• Act as (Single) Point of Contact and oversee clients' portfolios
• Submit registration and maintenance documents to regulatory agencies and carry out all the subsequent negotiations and activities necessary to obtain and maintain the marketing authorization for the products.
• Work closely with government agencies to ensure all legislation is closely followed and the clients' products comply with the regulations.

Translation Project Manager

• Generate quotation for clients, negotiate rates and deadlines with suppliers.
• Coordinate production with translators, proofreaders, in-country clients reviewers, typesetters and customer service representatives.
• Keep sales person/customer service representative up to date at all times via Status Reports.
• Keep all databases up to date at all times and maintain accurate records of all costs.
• Ensure all translation projects have properly enforced quality control according to Standard Operating Procedures.
• Assign and review the tasks and assess needs for additional information, e.g. compilation of glossaries, previously translated similar documents, list of acronyms, technical terminology, and translation memories.
• For current clients, research previous translation teams and reference material to ensure consistency.
• Identify issues and implement process improvements.

Medical Writer

• 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.

IDEAL CANDIDATE

Regulatory Affairs Project Manager

• Be proficient in written and spoken English; knowledge of other languages is a distinctive advantage.
• Understand project management principles.
• Knowledge of Product Life Cycle Management and EU regulations and guidelines is an advantage, experience of eCTD would also be beneficial.
• University degree or equivalent experience in Life Sciences (Chemistry, Pharmacology, Biology, Medicine, etc.) is an advantage.
• Be flexible and adaptable to changing project priorities and work assignments.
• Be able to work under strict timelines.
• Have excellent communication skills.

Translation Project Manager

• Previous experience in translation services is preferred.
• Fluency in English is a must.
• Strong computer skills (Word, Excel, PowerPoint, Acrobat, html, xml).
• Tech-savvy, good knowledge of Trados and Computer Aided Translation (CAT) tools is welcome.
• Ability to prioritise while handling multiple projects simultaneously in a fast-paced, time sensitive environment.
• Ability to communicate accurately detailed instructions to multilingual vendors.
• Detail and service oriented.
• Excellent interpersonal skills.

Medical Writer

• 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