Senior Director Medical Writing

We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved in Europe and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. S. biotechnology and pharmaceutical companies, today we are listed on the Taipei Exchange (6446) and are expanding our global presence with operations in the U.Japan, and China, along with a world-class biologics production facility in Taichung. Please double check you have the right level of experience and qualifications by reading the full overview of this opportunity below. The Senior Director, Medical Affairs role will identify and integrate the unmet needs and perspectives of healthcare providers, payers, patients, and caregivers into product and franchise Medical Affairs strategies. Lead the PharmaEssentia platform and product portfolio specific Medical Affairs strategy and execution Develop, execute and collaborate a highly efficient, integrated US medical affairs/scientific strategy Provide management and oversight of the Medical Affairs team which includes the US HEOR team, publication and scientific communication team, call center, Congress planning and KOL mapping and strategy Scientific evidence generation (RWE, HEOR, Phase IV and IIT) and scientific information exchange with all key stakeholders Involvement in the planning, strategy, tactics, slide deck development, and training of the MSL team. Strong collaboration with the MSL director Provide cross-functional support to MSLs, medical information, regulatory affairs and clinical development with medical and scientific expertise for life cycle management Provide relevant data evidence to ensure that the strategy is clearly defined and consistent with clinical development and commercial strategic objectives Review and approve medical and scientific content of Regulatory, Safety, Medical Affairs, and Commercial Support identification and management of and build relationships with key stakeholders Identify and review potential clinical study sites supporting Clinical Development in study-site engagement Education: PhD or PharmD required; Minimum of 10 years of relevant working experience in the Pharmaceutical/Biotechnology industry Minimum of 6 years of experience in Medical Affairs Ability to articulate complex scientific and medical information in understandable business terms Knowledgeable in regulatory guidelines and clinical terminology Ability to work independently and with a team with strong writing, communication, and project management skills Travel required - up to 25% Comprehensive medical coverage ~ Dental and vision coverage ~ 401(k) retirement plan xmcpwfu with competitive company match ~ Medical & Dependent Care Flexible Spending Account ~ Up to $150 monthly cell phone reimbursement ~ Employee Assistance Program ~ At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.