Manager/Sr. Manager, Regulatory Affairs (Medical Writer and Document Management)
Sirnaomics, Inc. is a leading clinical stage biopharmaceutical company in the discovery and development of RNAi therapeutics for treatment of cancer and fibrotic diseases. We are seeking candidates to fill the newly created position of Manager, Regulatory Affairs (Medical Writer and Document Management) reporting to the Head of Regulatory Affairs. The position can be either entirely remote or office based (in our Gaithersburg, MD headquarters).
The successful candidate will be assigned writing projects to support regulatory affairs in various stages of development and will also be responsible for Regulatory Affairs document management. Specifically, this position will prepare outlines, writings and quality assessments of regulatory documents for submissions, and be responsible for developing and maintaining templates, files and archives for regulatory correspondence and submissions, in compliance with regulatory affairs department or company policies, practices and procedures. In collaboration with the Head of Regulatory Affairs, this person may provide the project team for assigned project(s) with advice on writing or document control and management practices, and also assist in the development and implementation of functional area practices, policies, and procedures.
Additional responsibilities may include, but not necessarily be limited to, the following:
- Serve as day-to-day Regulatory Affairs Medical Writer to achieve project goals for regulatory affairs activities
- Collaborate with the Head of Regulatory Affairs to provide regulatory document management and control guidance to teams in support of cross-functional teams
- Develop and maintain a reference library for published literature, study reports and regulatory agency guidelines to support all projects.
- Stay abreast of the requirements for medical writing and document management and control through active participation in conferences and training
- Assist in preparing regulatory support materials for teams for regulatory agency interactions, including PowerPoint presentations, speaker’s notes and other documents, as required.
- Prepare templates for and QC documents for INDs, NDAs, CTAs, MAAs, annual reports, amendments and correspondence in collaboration with regulatory affairs project leads.
- Provide document formatting, preparation and quality assessment of documents for regulatory submissions
- Identify regulatory writing or document management issues proactively that may impact the assigned project(s) and discuss strategies to address them with the Head of Regulatory Affairs.
To be considered for this position, the successful candidate will have a Bachelors’ degree, or equivalent, in biological science, nursing, pharmacy or related discipline (an advanced degree is preferred) and five (5) or more years of related experience required (7 or more for the Senior Manager level), to include experience managing regulatory submissions and/or projects, to include the management of complex, multi-stakeholder projects and achieving goals is strongly preferred.
Desirable Skills and Characteristics
- Ability, reliability and willingness to work with the Head of Regulatory Affairs, Chief Medical Officer, clinical operations, other Sirnaomics staff, consultants and vendors from the incumbent’s remote office
- Excellent communication, verbal and written skills and familiarity with the requirements and etiquette of telephone and video conferences
- Robust word processing including, WORD, Excel, PDF, PowerPoint, software for designs, schematics and flow diagrams, literature reference and study report management tools, document organization and document management skills
- Prior experience in regulatory affairs, regulatory operations or a medical/technical writing role (s) within the pharmaceutical or biopharmaceutical industries desired but not a barrier
- Knowledge of and ability to interpret regulatory requirements and guidelines as well as familiarity with regulatory agency websites
- Flexibility and adaptability in order to take on new, unexpected or urgent activities, as required
- High level of interest in continuing learning in order to develop knowledge and new professional skills
Sirnaomics is an Equal Opportunity Employer, and offers a fast paced/dynamic environment, growth opportunity, competitive compensation and a full benefits program.
For consideration, please submit your resume to Talent@Sirnaomics.com. Only those candidates selected for an interview will be contacted.