Senior Manager Medical Writing
Company: Ascent Services Group
Location: San Diego
Posted on: April 8, 2021
We are seeking talented individuals who will thrive in our
collaborative, diverse, fast-paced environment and share in our
mission to identify, develop and deliver life-changing therapies to
people living with rare disease. We stick by our values centered on
patients, courage, community, and collaboration to pursue our
vision of becoming a leading biopharmaceutical company dedicated to
the delivery of innovation and hope to patients in the global rare
The Senior Manager, Medical Writing is responsible for oversight
and authoring (if needed) of regulatory, clinical, and safety
documents, including protocols and amendments, clinical study
reports (CSRs), Investigator's Brochures (IBs), Common Technical
Document (CTD) sections, and Periodic Safety Update Reports
(PSURs). This position is expected to contribute directly to the
drafting of high level (eg, Module 2) submission documents and be
responsible for overall project management during the drafting,
reviewing, and approving cycles of documents. This position will
oversee the drafting of documents that are compliant with
company-specific medical writing standards, are completed on-time
and on-budget, and are ready for submission to global, regional,
and local regulatory authorities. Additionally, this position will
support projects across all phases of clinical development and
post-marketing life cycle management.
- Lead the overall strategy and execution of medical writing
projects in support of therapeutic development programs.
- Collaborate with cross-functional team members to ensure
accurate and timely completion/delivery of high-quality,
- Responsible for the scientific accuracy and regulatory quality
assurance of developed content and deliverables.
- Responsible for implementation of medical writing review
- Communicate deliverables needed, writing process, and timelines
to team members.
- Contribute to the development and standardization of templates
and related processes and assist in the development of templates,
style guides, and SOPs for regulatory writing.
- Maintain expert knowledge of US and international regulations,
requirements and guidance associated with clinical, regulatory, and
safety document preparation and submissions.
- Lead and manage comment resolution meetings.
- Learn and apply knowledge of therapeutic area and product to
scientific writing projects.
- Develop, maintain, and drive document finalization timelines
and coordination of document review. Qualifications:
- Master's, PhD or PharmD in Life Science disciplines; equivalent
combination of education and applicable job experience may be
- Minimum 4 years of progressively responsible medical writing
experience in a biopharmaceutical/industry environment or 6+ years
at a Contract Research Organization (CRO) or related environment
- Proficiency with Microsoft Office, and VEEVA platforms and use
of Starting Point electronic document templates.
- Time management and project management skills are
- Knowledge of FDA, EMA, ICH, and other applicable guidelines and
- Experience or background in working within the pharmaceutical
industry, awareness of compliance issues and guidelines around
medical education and publications.
- Ability to manage various projects, solve problems, deliver on
commitments and work with multidisciplinary teams.
- Independent, self-starting individual with a demonstrated
ability to thrive in smaller company culture and environment is
- Strong interpersonal and organizational skills and excellent
verbal and written communication skills are required.
- Excellent collaboration skills with strong attention to detail
and the ability to multi-task and manage complexity. Divna
Rosenzweig is recruiting for this position. Corporate Office
1001 Galaxy Way, Suite 405
Concord, CA 94520
email@example.com Employment Verifications
Via The Work Number, employer code 105779 Additional office
locations in Chico, CA; Chicago, IL; Los Angeles, CA.
Keywords: Ascent Services Group, San Diego , Senior Manager Medical Writing, Healthcare , San Diego, California
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