Job Description

Company Summary :

Ascentage Pharma is a global, clinical-stage biotechnology company engaged in developing novel therapies for cancers, CHB, and senesce diseases. Ascentage is an integrated global biopharmaceutical company engaged in discovering, developing and commercializing both first- and best-in-class cancer therapies.

Ascentage Pharma is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of eight clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). The company is conducting more than 40 Phase I/II clinical trials in the US, Australia, Europe, and China. Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML), was granted Priority Review status and a Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) and is already approved for the indication. In addition, the olverembatinib was also granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EU. Please see for more information.

Position Summary:

The Medical Writer collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

Essential Duties and Responsibilities : To perform this job successfully, an individual must be able to perform the following:

• Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
• Participates in scientific communication planning, including development of strategic medical communication plans
• Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
• Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
• Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
• Collaborate with clinicians, clinical scientists, biostatisticians, and pharmacokinetics to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
• Manages the document review process ensuring conflicting comments are appropriately addressed
• Completes documents according to agreed-upon timelines and follow-up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance and reach consensus on timelines for deliverables
• Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
• Manages all aspects of outsourced or internal CSR production and ensures project delivery
• Ensures that medical writing deliverables conform to the International Conference on Harmonization (ICH) and other relevant regulatory guidelines
• Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
• Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
• Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates to improve quality, efficiency, and productivity
• Aligning with department management to set strategy for meeting department goals

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the experience, knowledge, skill, and/or ability required.

• Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases,clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
• Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
• Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
• Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
• Ability to utilize a balanced approach to problems, using flexibility and persistence as appropriate
• Read, write and speak fluent English, excellent verbal and written communication skills
• Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses.
• Excellent writing skills coupled with knowledge of the drug development process and regulatory guidelines.
• Effective collaborator with ability to foster strong working relationships and build consensus among colleagues on cross-functional teams.
• Initiative and ability to handle a variety of projects simultaneously.
• Excellent interpersonal and communication skills.
• Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT.

Education/Experience: The ideal candidate will offer:

• (BA/BS) +8 years, (MS) +5 years, (Ph.D. or PharmD) Doctoral Degree+2 years of relevant corporate medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas;
• 3 -8 years of regulatory writing and submission experience
• An understanding of the drug development process
• Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
• Experience in interacting with cross-functional study team members

Work Environment : This is a high growth, fast paced small organization. The successful candidate will be a self-starter, comfortable with autonomy, and embrace cross-functional collaboration as they successful navigate in this busy work environment.

• Medical, Dental and Vision Insurance
• Life Insurance; STD & LTD
• Paid Time Off
• 401k with Company Match
• Company parties and events
• Management and growth opportunity

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