Ascentage Pharma is hiring: Senior Medical Writer in Rockville

This range is provided by Ascentage Pharma. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$130,000.00/yr - $210,000.00/yr

Additional compensation types

Annual Bonus

Direct message the job poster from Ascentage Pharma

Employee Experience Advocate I HR Strategic Leader I Talent Champion

Company Summary: Ascentage Pharma – Who we are:

Ascentage Pharma (Nasdaq: AAPG and HKEX: 6855) is a global, clinical-stage biotechnology company developing novel therapies for cancer and other diseases. Based in China, with key operations in the US, Australia, and UK, Ascentage is proud of its collaborative and supportive culture, unified by a shared desire to develop therapeutics that will have a positive impact on patients’ lives. We are a dynamic and fast-paced organization with a robust pipeline and a science-driven culture defined by a shared understanding that it succeeds in advancing its mission only as each experience’s success in their role.

Following our recent IPO on NASDAQ, we are expanding our U.S. leadership team to keep our focus on the discovery, development, and commercialization of transformative therapies for oncology and hematology indications.

Please see www.ascentage.com for more information.

Position Summary:

The Sr. 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
• Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists 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 and/or ambiguous comments are clarified and appropriately addressed
• Works closely with the study team to reach consensus on timelines for deliverables
• Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
• 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 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 in order to improve quality, efficiency, and productivity
• Align with department management to set strategy for meeting department goals

Education/Experience: The ideal candidate will possess:

• At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
• Bachelor’s degree +8 years, Master’s Degree +5 years, Doctoral Degree+2 years of relevant medical writing experience in the pharmaceutical industry, especially writing in one or more of the oncology or rare diseases therapeutic areas; graduate degree (master’s or doctoral) preferred.
• RAPS Certification, Highly Desired.
• 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 Knowledge, Skills and Abilities:
• 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

Why Join Us- Our Value Proposition

This is a rare opportunity to shape the clinical vision of a public biotech at a pivotal growth moment—and see your work make a tangible impact for patients.

If you want to do something that matters—this work matters. Patients drive our passion to pioneer novel cancer therapies. Creating and delivering life-changing medicines requires focus, dedication, and heart. We hire exceptional people, trust them to do their best work, and support them with the resources and flexibility to thrive.

What We Offer

• Exciting, supportive, and intellectually challenging global work environment.
• Competitive benefits, including medical, dental, vision, disability, and life insurance, parental leave, and a matching 401(k) program (immediate vesting).
• Generous PTO and holidays encourage balance and recharge.
• A culture of engagement, diversity, inclusion, and empowerment.
• Flexibility to work onsite, remotely, or in a hybrid model.

Compensation and Benefits

At Ascentage, base pay is one part of a competitive total rewards package that includes comprehensive benefits (medical, dental, vision, 401(k), and more), equity, and the potential to receive annual target bonuses. Actual pay is based on factors such as location, experience, skills, education, and internal equity.

Ascentage Pharma also offers:

• We offer exceptional, Medical, Dental, and Vision plans for employees and families.
• Employee paid life, STD & LTD as well as a comprehensive insurance package with spouse life Insurance, Critical Illness, and Accident Insurance
• 401K with an immediate and generous company match
• Liberal paid time off
• Flexible schedules for staff and employee assistance program

Ascentage Pharma is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is Ascentage Pharma's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, marital status, status as a protected veteran, or any other legally protected group status.

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Writing/Editing, Research, and Science

• Industries

  Biotechnology Research, Pharmaceutical Manufacturing, and Public Health

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Disability insurance

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