Senior Specialist Disclosure Medical Writer

Job Description

The Medical Writing & Disclosure Department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results document disclosure and data sharing with external researchers.

Senior (Sr) Specialist Primary Responsibilities:

Authoring scientifically valid clinical trial registration and results postings on (United States NIH public disclosure registry) the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) registry the EU Clinical Trial Information System (CTIS) portal and the Heads of Medicines Agencies (HMA)- European Medicines Agency (EMA) Catalogue of Real World Data (RWD) Studies (formerly EU PAS) registry for studies of varying complexity and therapeutic designation.

Preparing study registration and results postings based on source documents (e.g. protocols CSRs) negotiating content with internal and external reviewers and guiding the posting through review and approval.

Collaborating with clinical teams including requesting necessary data and information to ensure compliance with applicable legal requirements (Section 801 of the Food and Drug Administration Amendments Act and the Final Rule for Clinical Trials Registration and Results Information Submission 42 Code of Federal Regulations Part 11 in the US and Directive 2001/20/European Commission and the Clinical Trials Regulation of the European Union).

Responding to internal and clinical review comments on public disclosures; amending disclosures as appropriate and incorporating review findings prior to finalizing for posting on public websites; and addressing NIH Quality Analysis review comments to resolve issues before resubmission when necessary.

Participating in weekly MW&D-Disclosure meetings and scheduling meetings as needed with external teams.

Assuring that Project Leads and management are informed of any problems or unresolved issues that could affect the timely completion of the work or the work quality.

Gaining expertise in the regulations associated with the disclosure of clinical study registrations and results in the United States and European Union and adapting to the changing regulatory environment as needed.

Providing feedback on Standard Operating Procedures and Working Instructions as appropriate.

As a secondary responsibility the Sr Specialist may occasionally prepare plain language (lay) summary trial results at a 6-8th grade reading level and provide input into the Health Literate Glossary.

In addition to the above Primary Responsibilities the Sr Specialist (Sr Disclosure Medical Writer) role within the Medical Writing and Disclosure (MWD) department also demonstrates leadership within the department and serves as a resource for consultation and/or training. Under the supervision of the Director a Sr Specialist will participate in one or more of the following Supplemental Leadership Activities.

Supplemental Leadership Activities:

Health Literacy (Plain Language Summary Authoring)

Media & Communications (Podcasts Disclosure Website Writers Room Meeting Hosting Lunch n Learns Presentations Conferences)

Mergers & Acquisitions (M&A Acquired Trial Disclosure GCTO Integration Workstream Representation)

Process Improvements and Strategic Initiatives (Guidance Document Creation and Maintenance BARDS Liaisonship GCTO Liaisonship (i.e. CSRs)

Quality & Consulting (Peer Consulting Buddy Support External Query Assistance)

Resourcing (Talent Sourcing Onboarding Distribution of Assignments)

Systems & Process (S&P Artificial Intelligence AI UAT PharmaCM Testing Creating/Maintaining SharePoint Trackers (i.e. Peer Consult Tracker)

Writer Development (Training myLearning Curriculum Stewardship/Administration)

Qualifications

Bachelors degree in Life Sciences or a related discipline.

Required Experience:

AT LEAST ONE of the following or similar:

Experience authoring protocol registrations and/or results disclosures on or EudraCT.

Experience in authoring International Council for Harmonisation clinical/regulatory documents (i.e. Clinical Study Reports Protocols etc.).

Experience in technical or medical writing familiarity with clinical research documents preferred.

Experience in medical publications or regulatory product labeling.

Required Skills:

Good communication and interpersonal skills (both oral and written) in order to interact clearly effectively and tactfully with stakeholders.

Strong attention to detail strong analytical/logical thinking skills; able to critically evaluate data.

Able to abstract information from source documents.

High degree of organization and ability to manage simultaneous projects.

Demonstrated team skills professional values and personal skills necessary for effective teamwork able to work in cross-functional environment.

Ability to work under pressure both independently and collaboratively in a team environment.

Work style focused on problem-solving and maximizing accuracy.

Familiarity with United States and/or European Union legislation for clinical trial registration and result disclosure.

In addition to the Required Experience and Required Skills above that are prescribed for the Specialist role the Sr Specialist should demonstrate the following leadership skills and behaviors.

Leadership Skills and Behaviors:

Reliability/Dependability proven ability to complete tasks on time and with a high level of quality

Flexibility/Adaptability ability to jump in and take on additional tasks even with a busy schedule. (e.g. meeting coverage urgent assignments fielding clinical queries)

Teamwork ability to easily and effectively collaborate on a variety of topics/projects demonstrating conflict resolution and negotiation expertise

Advanced Expertise comfortable discussing complex work with peers explaining study designs teaching new concepts helping other writers etc.

Initiative volunteers to take on new challenges or extra projects for specific issues (lead team meetings take on additional work investigate PCM issues etc.)

Innovation displays a creative focus on development and process improvement to address unmet needs

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Required Skills:

Preferred Skills:

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