Priya Mukherjee at CK Clinical is currently seeking an Associate Director, Clinical Submissions Writing Manager for a leadin
g pharmaceutical company
in Germany, to work within the Global Medical Writing/Clinical Submissions Writing department.
As a Clinical Submissions Writing Manager you will have the following the responsibilities:
- To manage up to 6 (senior) Medical Writers. Coach, train and mentor staff, thereby contributing to successful development, registration in key regions and commercialisation of new drugs and biologic agents, including important lifecycle management work (new line extensions, indications and/or formulations of late-stage development or already registered compounds).
- Ensure critical review and interpretation of clinical efficacy and safety data for appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
- Prepare clinical submission documents for a regulatory audience, within a team environment, according to SOPs.
- Manage review and approval process of clinical submissions documents, which includes authoring documents in a team environment, generating consensus among reviewers, and facilitating discussions in an efficient manner.
- Provide process, content, and submission/document planning expertise to the Clinical Submission Team, the Clinical Satellite Team, and the Clinical Trial Team.
- Advise the team on resource utilization, efficiencies, timelines, and interdependencies. Participate in and/or lead the development of processes and tools related to document authoring, management, and quality control in support of the departmental goal to develop best-in-class processes, tools, and standards to foster open communication, quality, efficiency, and cost-effectiveness of clinical document generation to support the delivery of high-quality documents within realistic and ambitious timelines.
- Share expertise within Medical Writing by coaching/mentoring (Senior) Medical Writers.
- Act as a Clinical Program Medical Writer.
- Provide process, content, and planning expertise to the Clinical Trial Team, the Clinical Satellite Team, and the Submission Team regarding document preparation, submission strategy and consistent scientific messaging.
- Advise the team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies.
- Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style. Coordinate with other Clinical Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications.
- Participate in and/or lead the development of processes and tools related to authoring and reviewing of clinical documents.
- Maintain and demonstrate expert knowledge of drug development process and applicable regulatory guidelines.
- Liaise with vendors/external contractors as assigned.
- Ensure timelines and quality of product when the writing of a document is outsourced.
Qualifications and skills:
Interested applicants for this Clinical Submissions Writing Manager role should have the following skills and qualifications:
- Bachelor’s degree (OR Equivalent)
- Proven experience in Medical Writing in the Biopharmaceutical industry including regulatory writing experience.
- Experience in people management and you are also able to coach and/or mentor more junior colleagues.
- Work methodically and you should have excellent written and verbal communication skills (also in English).
- The ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
How to apply:
For more information please contact Priya Mukherjee on +44 (0)207 470 5673 or email email@example.com. Please quote reference CL25358 in all correspondence.