Manager Data Transparency And Regulatory Disclosure

Summary / purpose of theposition

In collaboration withthe DTRD and crossfunctional teams the DTRD Manager is responsiblefor driving the endtoend processes of disclosure activities forassigned asset portfolio/s that result in timely and accuratedisclosure of Ipsen clinical data on public websites trackedappropriately.

The DTRD Manager is the point ofcontact for study teams asset leads and strategic partners tosupport with decisions and operations related to any datadisclosure/sharing activity associated with regulatory submissionsor as per agencies requests and local requirements.

In this new position the DTRD Manager applies strongproject management expertise and contribute to functionalexcellence through processes and technologies changes. The roleinvolves driving the implementation of strategies that aim tomaximize global efficiency and strategic alignment of IPSENdisclosure activities with external communication acrosstherapeutic areas.

The mission entails impartingknowledge to key stakeholders on best practices and fostering atransparency culture throughout the company by reinforcinginteractions with key partners.

Main responsibilities/ jobexpectations

The list below is anexhaustive list of potential activities and will be adjustedaccording to the profile.

Management of routinedisclosure activities

• Bringspecialized knowledge of global disclosure requirements andstandards to study/asset teams providing guidance on best practicesto ensure quality and confidentiality of information sharedpublicly as well as consistency of trial/product information acrossdisclosures.
• Assess the applicability ofclinical studies and submission dossiers (CTA MAA label variationsetc.) for disclosure in accordance with US EU laws and otherapplicable regulations or policies as well as Ipsenpolicy.
• Ensure study disclosure assessment istracked and filed and disclosure roadmap shared with relevantstakeholders in a timely manner.
• Review studyprotocols study documents and productrelated documents asapplicable to identify confidential information and determine itssuitability for disclosure.
• Act as DTRD Leadby actively participating in relevant asset or study meetings toraise awareness of requirements and associated disclosureactivities throughout the study and product life cycle.
• Plan and coordinate the endtoend preparation of thefollowing activities working closely with crossfunctionalstakeholders from the asset or study and the vendor.

1. o Study information for disclosureon public registries (i.e. ClinicalTrials.gov EU CTR CTIS EU PASRegister and local register as applicable).
2. oClinical trial lay protocol synopses and lay summaries.
3. o Anonymized/redacted documents or packages for publicdisclosure and submissions to agencies for journal publications oradhoc requests.

• Contribute to response to questions received by agencies onClinical Trial Applications Marketing Authorization Applicationsand other regulatory procedures as needed.
• Ensure the maintenance of detailed and uptodate tracking status forall studies documents packages posted on public websites as well asfor assetspecific commercially confidential information.
• Upload and maintain up to date documentation ofdisclosure activities in the eTMF and eDMS.
• Manage the shared mailboxes for internal and public enquiries byensuring that they are monitored and that replies are provided tostakeholders or dispatched as required and in compliance withapplicable guidance and regulations.

Vendor Management andBudgeting

Be accountable for andoversight work delegated to preferred vendors.

Plan budget needs per each outsourced activity.

Ensure optimal outsourcing strategy for disclosure activities bypartnership with procurement and in alignement topmanagement.

Awareness of relevantlegal regulatory and industry requirements

Perform a regulatory watch on disclosure and transparencyrequirements from agencies industry associations andcommunities.

Contribute to relevant industrycommunities.

Perform benchmark activities andmonitors emergences of standards in this area.

Participate to congress community calls conferences etc.

Track and inform team management and team members aboutnew requirements developments and latest updates asappropriate.

Global operationalexcellence support and transversalactivities

Participate or leadprocess improvement and digitalization/automation initiatives thatpromote strategic disclosures and operational excellence.

Contribute to the development and maintenance of StandardOperating Procedures and other documentation (e.g. QualityDocuments training/guidance material) to ensure effective

implementation ofprocesses.

Mentors more juniorstaff members.

Develop plan for integration ofnew assets including transfer of public documents and ensure itsexecution.

Assist senior management inestablishing and maintaining governance for data transparencyactivities at Ipsen while also ensuring that company policy is inaccordance with both regulations and industry standards.

Actively participate to or lead steering committeemeetings topics as needed.

Support and/orassume executive delegation of senior management in transversalprojects including but not limited to team scope of activities suchas overseeing EU CTR and championing Data Privacy.

Knowledge abilitiesexperience

Education /Certifications:

Bachelors ormasters degree in life sciences

Preferred forthis role:

Master or PhD graduated in adiscipline relevant to pharmaceutical industry.

Experience:

35 years in at least one of the following areas: clinicaldata disclosure/transparency regulatory affairs clinical operationsor consulting for RD projects in the pharmaceuticalindustry.

Good understanding of RD environmentand drug development process.

Wellversed inpreparing or reviewing clinical and/or regulatory documents and/orexperience in summarizing scientific information.

Proved experience in project management.

Preferred for thisrole:

Understand globalregulatory requirements and guidance for clinical trial disclosuree.g. FDAAA 801 and the Final Rule Final Rule EU Clinical TrialsRegulation No 536/2014 Good Pharmacovigilance Practices (GVP)module VIII.

Understand Global RegulatoryAffairs environment in particular Clinical Trial Application andMarketing Authorization Applications s and associated transparencyregulations (EMA Policy 70 and Health Canada PRCI).

Familiar with other transparency activities i.e.publications on journals plain language summaries voluntary datasharing.

Technicalskills:

Proficiency withMicrosoft Word Excel Power Point and other Officeapplications.

Experience working on platformslike Sharepoint Drive Teams etc.

Ability towork effectively with electronic document management system (eDMS)and trial master file (eTMF).

Familiarity withclinical trial management system(s) (CTMS) and clinical datarepository.

Working knowledge and familiaritywith clinical study public registry websites and databases e.g.ClinicalTrials.gov (PRS) EU CTR (EudraCT) EU Clinical TrialInformation System(CTIS).

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RemoteWork :

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